MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'CDRH Consumer News' source. Wed, 17 Aug 2011 03:58:41 +0100 http://www.medworm.com/index.php?rid=4962508&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FImplantsandProsthetics%2FBreastImplants%2Fdefault.htm Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction)... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=4962508 Wed, 22 Jun 2011 04:00:00 +0100 4962508 http://www.medworm.com/index.php?rid=4791169&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fconsumer%2F (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=4791169 Fri, 06 May 2011 04:00:00 +0100 4791169 http://www.medworm.com/index.php?rid=2732166&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm180073.htm Reason for Recall: These out-of-date devices may cause serious injury to infants or caregivers. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2732166 Tue, 25 Aug 2009 04:00:00 +0100 2732166 http://www.medworm.com/index.php?rid=2693564&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm177040.htm These teethers may contain harmful bacteria (Bacillus circulans and Bacillus subtilis) in the gel. Use of this product may result in diarrhea, respiratory illness, serious infection, and death. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2693564 Wed, 12 Aug 2009 04:00:00 +0100 2693564 http://www.medworm.com/index.php?rid=2676542&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm176124.htm Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2676542 Thu, 06 Aug 2009 04:00:00 +0100 2676542 http://www.medworm.com/index.php?rid=2676541&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm176129.htm The POWERSAIL Coronary Dilatation Catheter is used by physicians during medical procedures to dilate heart blood vessels or to dilate implantable stents. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2676541 Thu, 06 Aug 2009 04:00:00 +0100 2676541 http://www.medworm.com/index.php?rid=2672957&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm175886.htm The following are potential risks of the system: Failure of the Occlusion Warning Message to adequately guide users to clear blocked (occluded) IV tubing may result in under infusion. When the Alaris PC unit is used with the PCA module, the pump... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2672957 Wed, 05 Aug 2009 04:00:00 +0100 2672957 http://www.medworm.com/index.php?rid=2669327&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm175797.htm The TAXUS® Liberte? Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2669327 Tue, 04 Aug 2009 04:00:00 +0100 2669327 http://www.medworm.com/index.php?rid=2623691&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm172837.htm These infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may cause serious injury or death. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2623691 Tue, 21 Jul 2009 04:00:00 +0100 2623691 http://www.medworm.com/index.php?rid=2586294&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm171194.htm Reason for Recall: Power supply failures have occurred on some ventilators. A power surge may exceed the power supply capacity, causing the power supply to lose power. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2586294 Thu, 09 Jul 2009 04:00:00 +0100 2586294 http://www.medworm.com/index.php?rid=2554380&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm169592.htm The TAXUS® Liberté® Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2554380 Mon, 29 Jun 2009 04:00:00 +0100 2554380 http://www.medworm.com/index.php?rid=2480267&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FSafety%2FRecallsCorrectionsRemovals%2FListofRecalls%2Fucm166344.htm Reason for Recall: The Kappa and Sigma pacemakers in these identified series may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2480267 Fri, 12 Jun 2009 04:00:00 +0100 2480267 http://www.medworm.com/index.php?rid=2444383&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm162968.htm The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2444383 Wed, 27 May 2009 04:00:00 +0100 2444383 http://www.medworm.com/index.php?rid=2419659&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-042309.html This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2419659 Mon, 18 May 2009 04:00:00 +0100 2419659 http://www.medworm.com/index.php?rid=2400748&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070005.html REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2400748 Thu, 07 May 2009 04:00:00 +0100 2400748 http://www.medworm.com/index.php?rid=2400747&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-042709.html Reason for Recall: The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, CK-MB, and myoglobin, possibly resulting in missed or incorrect diagnosis. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2400747 Thu, 07 May 2009 04:00:00 +0100 2400747 http://www.medworm.com/index.php?rid=2334858&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080006.html The Medtronic® Attain Ability? Model 4196 Lead (Model 4196) is a surgically implanted insulated wire that is designed to be used as part of a biventricular pacemaker system. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334858 Fri, 17 Apr 2009 04:00:00 +0100 2334858 http://www.medworm.com/index.php?rid=2334857&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080023.html The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334857 Fri, 17 Apr 2009 04:00:00 +0100 2334857 http://www.medworm.com/index.php?rid=2334859&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-020209.html Reason for Recall: The faulty connector of the pump tubing assembly may result in the volume setting on the pump to default to 2.5 ccs or 5 ccs (depending on the Intra-Aortic Balloon Pump model) rather than the appropriate 30, 40, or 50 cc volume. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334859 Wed, 15 Apr 2009 04:00:00 +0100 2334859 http://www.medworm.com/index.php?rid=2334863&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP940015S012.html Synvisc-One? (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan polymers (derivatives of hyaluronan or sodium hyaluronate) produced from chicken combs. Synvisc-One is a single 6 mL injection treatment regimen. The total... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334863 Mon, 13 Apr 2009 04:00:00 +0100 2334863 http://www.medworm.com/index.php?rid=2334862&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080002.html The FC2 female condom is a sheath with one open end. There is an outer ring at the open end, and, although not attached to the condom, there is an inner ring inside the sheath that aids in insertion. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334862 Mon, 13 Apr 2009 04:00:00 +0100 2334862 http://www.medworm.com/index.php?rid=2334861&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080014.html These reagents are used with the Invader Call Reporter TM softwareto identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. If test results are positive, the patient is likely to... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334861 Mon, 13 Apr 2009 04:00:00 +0100 2334861 http://www.medworm.com/index.php?rid=2334860&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080015.html These reagents are used with the Invader Call ReporterTM software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334860 Mon, 13 Apr 2009 04:00:00 +0100 2334860 http://www.medworm.com/index.php?rid=2334864&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-021209b.html This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients having a heart attack (cardiac arrest). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334864 Wed, 08 Apr 2009 04:00:00 +0100 2334864 http://www.medworm.com/index.php?rid=2334865&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-011409.html Reason for Recall: The weak package sealing may affect the sterility of the devices. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2334865 Fri, 03 Apr 2009 04:00:00 +0100 2334865 http://www.medworm.com/index.php?rid=2310130&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-011409.html Reason for Recall: The weak package sealing may affect the sterility of the devices. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2310130 Fri, 03 Apr 2009 04:00:00 +0100 2310130 http://www.medworm.com/index.php?rid=2310131&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-021209.html Reason for Recall: The ventricular catheter may become detached from the snap base assembly after implantation and may increase the need for emergency corrective surgery. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2310131 Fri, 27 Mar 2009 04:00:00 +0100 2310131 http://www.medworm.com/index.php?rid=2270154&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-121508.html The device may experience: Low defibrillation energy delivery, Unexpected device shutdown, and/or Inadequate filtering of electromagnetic noise. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2270154 Mon, 16 Mar 2009 04:00:00 +0100 2270154 http://www.medworm.com/index.php?rid=2264653&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-012309.html Reason for Recall: The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2264653 Wed, 11 Mar 2009 04:00:00 +0100 2264653 http://www.medworm.com/index.php?rid=2252202&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080021.html The AVS, Inc. XACT ® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is plastic lens used to replace the natural lens after it is removed during cataract surgery to restore vision. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2252202 Mon, 09 Mar 2009 04:00:00 +0100 2252202 http://www.medworm.com/index.php?rid=2252201&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP030031S011.html The NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an intermittent abnormal heartbeat in the upper chambers of the heart (paroxysmal atrial fibrillation). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2252201 Mon, 09 Mar 2009 04:00:00 +0100 2252201 http://www.medworm.com/index.php?rid=2252200&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070014.html The LifeStent FlexStar and FlexStar XL Vascular Stent Systems are used to re-open stenotic (narrowed) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2252200 Mon, 09 Mar 2009 04:00:00 +0100 2252200 http://www.medworm.com/index.php?rid=2252198&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-011409.html Reason for Recall: The company has recalled this product because of complaints received about difficulty inserting: 1) the device used to place the tracheostomy tube into the windpipe (obturator), and/or 2) a suction tube (catheter) into... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2252198 Mon, 09 Mar 2009 04:00:00 +0100 2252198 http://www.medworm.com/index.php?rid=2229646&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH050003.html What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2229646 Tue, 03 Mar 2009 05:00:00 +0100 2229646 http://www.medworm.com/index.php?rid=2146242&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080010.html The TECNIS® Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2146242 Fri, 30 Jan 2009 05:00:00 +0100 2146242 http://www.medworm.com/index.php?rid=2139857&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060006.html The Express® SD Renal Monorail® Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and it consists of two components, the stent and the delivery system. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2139857 Wed, 28 Jan 2009 05:00:00 +0100 2139857 http://www.medworm.com/index.php?rid=2139856&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080011.html BIOFINITY® is an extended wear soft contact lens that may be worn continuously for up to 6 nights and 7 days. The lens material is approximately 48% water and 52% comfilcon A (a silicone-containing hydrogel). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2139856 Wed, 28 Jan 2009 05:00:00 +0100 2139856 http://www.medworm.com/index.php?rid=2063969&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-102408.html Reason for Recall: The company is recalling these products because sterility cannot be assured. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2063969 Wed, 24 Dec 2008 05:00:00 +0100 2063969 http://www.medworm.com/index.php?rid=2050183&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-042707a.html A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2050183 Fri, 19 Dec 2008 05:00:00 +0100 2050183 http://www.medworm.com/index.php?rid=2030943&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-100308.html Reason for Recall: These devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2030943 Thu, 11 Dec 2008 05:00:00 +0100 2030943 http://www.medworm.com/index.php?rid=2030942&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080007.html The E-LUMINEXX Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2030942 Thu, 11 Dec 2008 05:00:00 +0100 2030942 http://www.medworm.com/index.php?rid=2024218&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-102908.html Reason for Recall: Some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome (TASS) in patients following surgery. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2024218 Wed, 10 Dec 2008 05:00:00 +0100 2024218 http://www.medworm.com/index.php?rid=2015091&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmdufma%2Freport-tanning.html Section 230 of the FDAAA requires FDA to make certain determinations regarding the effectiveness of warning labels for indoor tanning devices in conveying information to consumers regarding the risks that such devices pose for the development of... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=2015091 Fri, 05 Dec 2008 05:00:00 +0100 2015091 http://www.medworm.com/index.php?rid=1987653&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060030.html This laboratory test measures the amount of hepatitis C viral RNA in a patient?s blood. Viral RNA (ribonucleic acid) is genetic material from the hepatitis C virus. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1987653 Wed, 26 Nov 2008 05:00:00 +0100 1987653 http://www.medworm.com/index.php?rid=1978428&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050029.html The Helios II Ablation Catheter is a magnetically guided catheter that is used to treat certain kinds of abnormal heart rhythms (arrhythmia) by finding the source of the rhythm disturbances and destroying (ablating) small areas of heart tissue. The... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1978428 Fri, 21 Nov 2008 05:00:00 +0100 1978428 http://www.medworm.com/index.php?rid=1978427&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050019.html The Carotid WALLSTENT ® Monorail ® Endoprosthesis is an implant used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to the brain. This device consists of the stent and a stent delivery system... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1978427 Fri, 21 Nov 2008 05:00:00 +0100 1978427 http://www.medworm.com/index.php?rid=1972535&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-080408.html There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1972535 Thu, 20 Nov 2008 05:00:00 +0100 1972535 http://www.medworm.com/index.php?rid=1936637&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-100908.html Reason for Recall: Some packages were mislabeled. The syringes labeled for use with U-40 unit insulin were mixed with syringes labeled for use with U-100 insulin. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1936637 Thu, 06 Nov 2008 05:00:00 +0100 1936637 http://www.medworm.com/index.php?rid=1922842&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-100108.html Reason for Recall: This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1922842 Fri, 31 Oct 2008 04:00:00 +0100 1922842 http://www.medworm.com/index.php?rid=1893337&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fconsumer%2Fsurgicalmesh-popsui.html FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1893337 Tue, 21 Oct 2008 04:00:00 +0100 1893337 http://www.medworm.com/index.php?rid=1893336&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fconsumer%2Fsurgicalmesh-hernias.html FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1893336 Tue, 21 Oct 2008 04:00:00 +0100 1893336 http://www.medworm.com/index.php?rid=1874586&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcellphones%2F Topics: Cellular Phones (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1874586 Tue, 14 Oct 2008 04:00:00 +0100 1874586 http://www.medworm.com/index.php?rid=1849616&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-062508.html Reason for Recall: This device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1849616 Fri, 03 Oct 2008 04:00:00 +0100 1849616 http://www.medworm.com/index.php?rid=1846742&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080004.html The Hoya iSpheric™ Model YA-60BB IOL is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1846742 Thu, 02 Oct 2008 04:00:00 +0100 1846742 http://www.medworm.com/index.php?rid=1846741&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050028.html The COBAS Taqman HBV Test For Use With The High Pure System is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA (deoxyribonucleic acid) is the... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1846741 Thu, 02 Oct 2008 04:00:00 +0100 1846741 http://www.medworm.com/index.php?rid=1846740&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060022.html Akreos ® posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1846740 Thu, 02 Oct 2008 04:00:00 +0100 1846740 http://www.medworm.com/index.php?rid=1842993&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-062608.html This recall is being conducted due to potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1842993 Wed, 01 Oct 2008 04:00:00 +0100 1842993 http://www.medworm.com/index.php?rid=1804764&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmaturityhealthmatters%2F This online newsletter about FDA regulated products for older adults and their caregivers. It focuses on FDA approved products that help people live longer, more productive lives. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1804764 Thu, 18 Sep 2008 04:00:00 +0100 1804764 http://www.medworm.com/index.php?rid=1785036&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-082808.html Reason for Recall: The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1785036 Thu, 11 Sep 2008 04:00:00 +0100 1785036 http://www.medworm.com/index.php?rid=1737131&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-090807.html Reason for Recall: The mobile oxygen storage tank?s pressure gauge may rupture and the device may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1737131 Thu, 28 Aug 2008 04:00:00 +0100 1737131 http://www.medworm.com/index.php?rid=1719134&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070006.html T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1719134 Wed, 20 Aug 2008 04:00:00 +0100 1719134 http://www.medworm.com/index.php?rid=1706616&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-060608.html The tip of the stent delivery system may detach from the delivery system during the procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Recall does not affect... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1706616 Thu, 14 Aug 2008 04:00:00 +0100 1706616 http://www.medworm.com/index.php?rid=1673215&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-031708.html Reason for Recall: Use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1673215 Fri, 01 Aug 2008 04:00:00 +0100 1673215 http://www.medworm.com/index.php?rid=1673214&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050040.html The SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1673214 Fri, 01 Aug 2008 04:00:00 +0100 1673214 http://www.medworm.com/index.php?rid=1654260&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070013.html Evolence® Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1654260 Fri, 25 Jul 2008 04:00:00 +0100 1654260 http://www.medworm.com/index.php?rid=1612688&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060039.html The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over.. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1612688 Fri, 11 Jul 2008 04:00:00 +0100 1612688 http://www.medworm.com/index.php?rid=1574328&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070016.html The Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1574328 Thu, 03 Jul 2008 04:00:00 +0100 1574328 http://www.medworm.com/index.php?rid=1574327&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070015.html The XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1574327 Thu, 03 Jul 2008 04:00:00 +0100 1574327 http://www.medworm.com/index.php?rid=1515085&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070008.html The Stratos LV (-T) Cardiac Resynchronization Therapy Pacemakers (CRT-P) are rate adaptive pulse generators that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1515085 Fri, 13 Jun 2008 04:00:00 +0100 1515085 http://www.medworm.com/index.php?rid=1505256&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070007.html The Talent™ Thoracic Stent Graft System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Thoracic Stent Graft System is made of a fabric tube... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1505256 Tue, 10 Jun 2008 04:00:00 +0100 1505256 http://www.medworm.com/index.php?rid=1505255&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060027.html The Ovatio CRT-D System is used to help treat congestive heart failure, a condition where the heart can not adequately pump blood around the body. It does this by providing specially timed electrical impulses to simultaneously stimulate... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1505255 Tue, 10 Jun 2008 04:00:00 +0100 1505255 http://www.medworm.com/index.php?rid=1421379&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060040.html The HeartMate II LVAS is a left ventricular assist device (LVAD) system; a device that helps the heart?s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1421379 Tue, 06 May 2008 04:00:00 +0100 1421379 http://www.medworm.com/index.php?rid=1378594&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070027.html The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1378594 Thu, 17 Apr 2008 04:00:00 +0100 1378594 http://www.medworm.com/index.php?rid=1365561&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP010012S037.html The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1365561 Fri, 11 Apr 2008 04:00:00 +0100 1365561 http://www.medworm.com/index.php?rid=1333377&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050020.html The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1333377 Fri, 28 Mar 2008 04:00:00 +0100 1333377 http://www.medworm.com/index.php?rid=1333376&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050045.html Topics: Breast Cancer, Diagnostic Tests (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1333376 Fri, 28 Mar 2008 04:00:00 +0100 1333376 http://www.medworm.com/index.php?rid=1319930&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-012108.html Reason for Recall: The company updated the labeling for the devices to include current patient management and treatment recommendations. The company also received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters.. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1319930 Fri, 21 Mar 2008 04:00:00 +0100 1319930 http://www.medworm.com/index.php?rid=1292911&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Foivd%2Ftest-strips.html The US Food and Drug Administration, Abbott Diabetes Care, and LifeScan are aware of instances where incorrect results were obtained using LifeScan OneTouch® Ultra® test strips with Abbott Precision Xtra® meters. OneTouch®... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1292911 Tue, 11 Mar 2008 04:00:00 +0100 1292911 http://www.medworm.com/index.php?rid=1290418&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-021208.html The company recalled these products because of consumer reports of first, second, and third degree burns, skin irritation, and skin removal... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1290418 Mon, 10 Mar 2008 04:00:00 +0100 1290418 http://www.medworm.com/index.php?rid=1254415&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fsafety%2Ficyhot-qa.html Chattem, Inc. chose to recall their Icy Hot Heat Therapy products because they received consumer reports of first, second and third degree burns as well as skin irritation and skin removal resulting from the use of the Icy Hot Heat Therapy... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1254415 Mon, 25 Feb 2008 05:00:00 +0100 1254415 http://www.medworm.com/index.php?rid=1254414&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmedicaldevicesafety%2Fatp%2F022508-denturecleansers.html FDA is asking the manufacturers of denture cleansers to revise labeling and to consider appropriate alternatives to an ingredient in their products. This action is in response to reports of 73 severe reactions linked to these cleansers, including at... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1254414 Mon, 25 Feb 2008 05:00:00 +0100 1254414 http://www.medworm.com/index.php?rid=1224139&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060033.html The Endeavor® Zotarolimus-Eluting Coronary Stent is a tiny, expandable, mesh-like tube made of a cobalt-based metal with a drug (called zotarolimus) contained within a thin polymer coating on its surface. The Stent is mounted over a deflated... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1224139 Tue, 12 Feb 2008 05:00:00 +0100 1224139 http://www.medworm.com/index.php?rid=1221752&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FK063765.html The xTAG™ Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections. Acute... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1221752 Mon, 11 Feb 2008 05:00:00 +0100 1221752 http://www.medworm.com/index.php?rid=1199189&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-080307.html There is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors that were manufactured before September 1999. These pumps can stall at a higher rate due to gear shaft wear. If a pump motor stalls, drug delivery will... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1199189 Mon, 04 Feb 2008 05:00:00 +0100 1199189 http://www.medworm.com/index.php?rid=1187770&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-122007.html Some end-user samples of Pre-Filled Heparin Lock Flush syringes, Product Code 1003-02, Lot 070926H, were found to be contaminated with a bacteria (Serratia marcescens) which resulted in patient bloodstream infections. The Centers for Disease Control... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1187770 Wed, 30 Jan 2008 05:00:00 +0100 1187770 http://www.medworm.com/index.php?rid=1182187&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fwrinklefillers%2F Injectable cosmetic wrinkle fillers are soft tissue fillers approved by the Food and Drug Administration (FDA) to help fill in facial wrinkles, restoring a smoother appearance. Most of these injectable wrinkle fillers are temporary, because they are... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1182187 Mon, 28 Jan 2008 05:00:00 +0100 1182187 http://www.medworm.com/index.php?rid=1176667&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-011408.html Reason for Recall: The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1176667 Fri, 25 Jan 2008 05:00:00 +0100 1176667 http://www.medworm.com/index.php?rid=1144160&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-102907.html During the manufacturing or servicing of the mechanism assembly, the occluder springs were misassembled (overlapping [nested], missing, bent or broken). If a spring is misassembled, there is a potential for inaccurate flow rate which may lead to a... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1144160 Fri, 11 Jan 2008 05:00:00 +0100 1144160 http://www.medworm.com/index.php?rid=1110403&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp070001.html The ProDisc™-C Total Disc Replacement is a device made from metal and plastic that is placed between two adjacent vertebral bodies (neck bones) to replace a diseased cervical disc. The ProDisc™-C Total Disc Replacement consists of three parts... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1110403 Fri, 21 Dec 2007 05:00:00 +0100 1110403 http://www.medworm.com/index.php?rid=1099220&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmaturityhealthmatters%2Fissue7.html FDA Health News for Older Adults, Their Families and Caregivers (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1099220 Mon, 17 Dec 2007 05:00:00 +0100 1099220 http://www.medworm.com/index.php?rid=1089358&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060037.html The NexGen ® LPS-Flex Mobile Bearing Knee and LPS-Mobile Bearing Knee are artificial mobile bearing knee systems that are designed to replace the knee joint. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1089358 Wed, 12 Dec 2007 05:00:00 +0100 1089358 http://www.medworm.com/index.php?rid=1089357&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060035.html The ARCHITECT ® CORE-M is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. ARCHITECT® CORE-M Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with HBV infection. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1089357 Wed, 12 Dec 2007 05:00:00 +0100 1089357 http://www.medworm.com/index.php?rid=1031701&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-101907.html The current Instructions for Use state that IVADs may be implanted or placed in the external position. If the IVAD is placed in the external position, air leaks may develop in the pneumatic driveline. These air leaks are a result of sharp bending of... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1031701 Fri, 16 Nov 2007 05:00:00 +0100 1031701 http://www.medworm.com/index.php?rid=1031700&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060038.html The Mitroflow Aortic Pericardial Heart Valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The Mitroflow valve consists of a single piece of bovine pericardium that is preserved with... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1031700 Fri, 16 Nov 2007 05:00:00 +0100 1031700 http://www.medworm.com/index.php?rid=1031699&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070012.html The Exponent® Self-Expanding Carotid Stent with Over-the-Wire (OTW) Delivery System and the Exponent® Self-Expanding Carotid Stent with Rapid-Exchange (RX) Delivery System are used to re-open stenotic (narrowed) regions of the carotid arteries... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=1031699 Fri, 16 Nov 2007 05:00:00 +0100 1031699 http://www.medworm.com/index.php?rid=999963&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-102607.html There is a possibility that these recalled devices may experience failure or unacceptable delay in analyzing a patient?s ECG resulting in possible failure to deliver the appropriate therapy. The possible failure or delay depends on the location of the... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=999963 Fri, 02 Nov 2007 04:00:00 +0100 999963 http://www.medworm.com/index.php?rid=981131&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH990002.html Epicel® cultured epidermal autografts (CEAs), or skin grafts, are sheets of autologous keratinocytes (skin cells) used to replace the epidermal, or top layer of skin on severely burned patients. The patient?s own skin cells are grown or cultured from a... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=981131 Fri, 26 Oct 2007 04:00:00 +0100 981131 http://www.medworm.com/index.php?rid=975323&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070009.html The REALIZE™ Band is a surgically implanted device used to help a person lose weight. The REALIZE™ Band consists of a silicone band, tubing, and an injection port. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=975323 Wed, 24 Oct 2007 04:00:00 +0100 975323 http://www.medworm.com/index.php?rid=957928&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-101507.html These leads are being recalled because a small number of 'fractures' have been detected. When the lead breaks ('fractures'), it may send false signals that cause inappropriate shocks or therapies such as pacing or shocks may not be... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=957928 Wed, 17 Oct 2007 04:00:00 +0100 957928 http://www.medworm.com/index.php?rid=940455&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmedicaldevicesafety%2Fatp%2F101007-cochlear.html This Advice for Patients is to remind you of the increased and life-threatening risk of bacterial meningitis in cochlear implant patients and the importance of their being fully vaccinated. Cochlear implant patients appear to be at some increased risk... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=940455 Wed, 10 Oct 2007 04:00:00 +0100 940455 http://www.medworm.com/index.php?rid=907535&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-062707.html A software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=907535 Thu, 27 Sep 2007 04:00:00 +0100 907535 http://www.medworm.com/index.php?rid=901579&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-081507.html A field service technician did not perform all of the hardware Recall: upgrades required in accordance with Baxter?s corrective action procedures related to eight open Colleague recalls. The service technician certified in the service documentation... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=901579 Tue, 25 Sep 2007 04:00:00 +0100 901579 http://www.medworm.com/index.php?rid=894798&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP040040.html The AMPLATZER ® Muscular VSD Occluder is a device placed via a catheter into the muscular ventricular septum, which separates the two ventricles of the heart, in order to close a hole, known as a ventricular septal defect (VSD). The device consists of... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=894798 Mon, 24 Sep 2007 04:00:00 +0100 894798 http://www.medworm.com/index.php?rid=884445&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp050043.html The Femoral Introducer Sheath and Hemostasis Device (FISH™) is used to stop bleeding at a puncture site following 5, 6, or 8 French diagnostic, cardiac catheterization procedures. Instead of using manual compression (using the hands) or mechanical... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=884445 Wed, 19 Sep 2007 04:00:00 +0100 884445 http://www.medworm.com/index.php?rid=880847&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-082407.html These recalled devices may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=880847 Tue, 18 Sep 2007 04:00:00 +0100 880847 http://www.medworm.com/index.php?rid=812819&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060002.html The FLAIR Endovascular Stent Graft is used to treat a stenosis, a narrowing or blockage, which has developed at the connection of a vein and an arteriovenous (A-V) access graft, known as the venous anastomosis. An A-V access graft acts as an artificial... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=812819 Tue, 21 Aug 2007 04:00:00 +0100 812819 http://www.medworm.com/index.php?rid=810262&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050024.html An ?ablation catheter? is a plastic tube used to destroy (ablate) abnormal tissue or tissue that allows a rapid heart beat to occur. The CryoCor Cryoablation System causes ablation by applying extreme cold at the tip of the catheter, destroying the... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=810262 Mon, 20 Aug 2007 04:00:00 +0100 810262 http://www.medworm.com/index.php?rid=804855&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-042307.html Reason for Recall: The display rotates around its mount and may result in the wire coming out of the casing. The wire may short circuit, resulting in a spark, smoke, or flame... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=804855 Fri, 17 Aug 2007 04:00:00 +0100 804855 http://www.medworm.com/index.php?rid=796360&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP930016s025.html These devices include a refractive excimer laser system that uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye according to the treatment plan; an eyetracker that detects the position of the eye and... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=796360 Mon, 13 Aug 2007 04:00:00 +0100 796360 http://www.medworm.com/index.php?rid=787262&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-062107.html The firm identified repair, inspection & test data sheets, which included electrical safety data, for the pumps, that were falsified. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=787262 Wed, 08 Aug 2007 04:00:00 +0100 787262 http://www.medworm.com/index.php?rid=782147&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FK061542.html The Binax Now® Malaria Test is a rapid laboratory antigen test that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. This is the first FDA product cleared for detection and identification of... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=782147 Mon, 06 Aug 2007 04:00:00 +0100 782147 http://www.medworm.com/index.php?rid=776554&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Ftanning%2F This site is intended to provide a source of general information on skin tanning, Ultraviolet (UV) exposure, UV emitting products, and skin protection... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=776554 Fri, 03 Aug 2007 04:00:00 +0100 776554 http://www.medworm.com/index.php?rid=776553&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060017.html The GeneSearch BLN Test Kit is a qualitative in vitro diagnostic test for the rapid detection of metastases larger than 0.2 mm in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. (See explanation of sentinel lymph node... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=776553 Fri, 03 Aug 2007 04:00:00 +0100 776553 http://www.medworm.com/index.php?rid=772067&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-052507.html Reason for Recall: There is a recent increase of a rare but serious infection in people who wear soft contact lenses. The infection is Acanthamoeba keratitis, caused by a parasite commonly found in nature. Acanthamoeba keratitis can cause permanent.. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=772067 Wed, 01 Aug 2007 04:00:00 +0100 772067 http://www.medworm.com/index.php?rid=769536&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmaturityhealthmatters%2F This online newsletter about FDA regulated products for older adults and their caregivers. It focuses on FDA approved products that help people live longer, more productive lives. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=769536 Tue, 31 Jul 2007 04:00:00 +0100 769536 http://www.medworm.com/index.php?rid=762104&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050016.html The Cormet Hip Resurfacing System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The Cormet System is called a resurfacing prosthesis because only the surface of the femoral head (ball)... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=762104 Fri, 27 Jul 2007 04:00:00 +0100 762104 http://www.medworm.com/index.php?rid=762103&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-062107.html The firm identified repair, inspection & test data sheets, which included electrical safety data, for the pumps, that were falsified. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=762103 Fri, 27 Jul 2007 04:00:00 +0100 762103 http://www.medworm.com/index.php?rid=759225&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-060807.html VAD support for the patient?s circulatory system may fail. The VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours). The compressor motor can stop without warning... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=759225 Thu, 26 Jul 2007 04:00:00 +0100 759225 http://www.medworm.com/index.php?rid=759224&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-033007.html The PVAD may contain a black collet (circular rim) that holds a rod-like piece in place (nut). This black collet and nut was intended to be used with a cannula (a small tube) of an older design that had a larger diameter... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=759224 Thu, 26 Jul 2007 04:00:00 +0100 759224 http://www.medworm.com/index.php?rid=757136&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fsafety%2F071207-heatingpads-qa.html Heating Pads are flexible fabric-covered pads containing electrical heating elements with a removable fabric cover. They usually operate from household current and are used to apply heat to the body to treat sore muscles or joints... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=757136 Wed, 25 Jul 2007 04:00:00 +0100 757136 http://www.medworm.com/index.php?rid=745138&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-062007.html A software irregularity causes the newly upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=745138 Fri, 20 Jul 2007 04:00:00 +0100 745138 http://www.medworm.com/index.php?rid=741826&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060018.html The PRESTIGE® Cervical Disc System is a two-piece metal device that is attached to adjacent vertebral bodies (neck bones) with bone screws to replace a diseased cervical disc. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=741826 Wed, 18 Jul 2007 04:00:00 +0100 741826 http://www.medworm.com/index.php?rid=741825&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP040024S006.html Perlane® is composed of transparent, viscous gel particles of hyaluronic acid that are implanted into facial tissue to provide volume in or just under the skin to smooth wrinkles and folds, especially around the nose, mouth and under the edges of the... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=741825 Wed, 18 Jul 2007 04:00:00 +0100 741825 http://www.medworm.com/index.php?rid=731505&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-060607.html Reason for Recall: The meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Contractors change the meters to the appropriate units of... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=731505 Fri, 13 Jul 2007 04:00:00 +0100 731505 http://www.medworm.com/index.php?rid=730075&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmedicaldevicesafety%2Fatp%2F071207-heatingpads.html On February 9, 2007, HoMedics, Inc. recalled their TheraP model heating pads after receiving complaints from users that these products had caused fires and burns. For a complete list of the recalled pads, see article. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=730075 Thu, 12 Jul 2007 04:00:00 +0100 730075 http://www.medworm.com/index.php?rid=720782&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp050039.html The NOVATION™ Ceramic Articulation Hip System is an alumina ceramic artificial hip replacement system, surgically implanted to completely replace a diseased or damaged hip joint. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=720782 Mon, 09 Jul 2007 04:00:00 +0100 720782 http://www.medworm.com/index.php?rid=720781&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fk051338.html The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=720781 Mon, 09 Jul 2007 04:00:00 +0100 720781 http://www.medworm.com/index.php?rid=694614&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050012S001.html The STS-7 Continuous Glucose Monitoring System is a glucose sensor for home use that reports glucose values every 5 minutes for up to 7 days before a new sensor must be inserted. These readings are used with fingerstick glucose measurements to detect... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=694614 Mon, 25 Jun 2007 04:00:00 +0100 694614 http://www.medworm.com/index.php?rid=678907&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060034.html The MONOLISA™ Anti-HBc IgM EIA is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV core antigen. Presence... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=678907 Fri, 15 Jun 2007 04:00:00 +0100 678907 http://www.medworm.com/index.php?rid=663691&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-030807.html A small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-I (i.e., less then 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=663691 Fri, 08 Jun 2007 04:00:00 +0100 663691 http://www.medworm.com/index.php?rid=656239&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-022107.html The use of Alcon Refractive Horizon, Inc.`s CustomCornea® algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7) with the LADAR6000 (TM) Excimer Laser caused corneal abnormalities (``central islands``). It also resulted in... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=656239 Mon, 04 Jun 2007 04:00:00 +0100 656239 http://www.medworm.com/index.php?rid=652982&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060011.html C-flex™ is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting in loss of vision. Cataracts... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=652982 Fri, 01 Jun 2007 04:00:00 +0100 652982 http://www.medworm.com/index.php?rid=647371&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-050407.html The environmental controls and processes used to manufacture these devices within the Shelhigh, Inc. facility in Union, New Jersey can compromise the sterility of these products. The use of non-sterile products in patients can lead to life-threatening... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=647371 Thu, 31 May 2007 04:00:00 +0100 647371 http://www.medworm.com/index.php?rid=647370&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmedicaldevicesafety%2Fatp%2F053107-acanthamoeba.html FDA has learned of a recent increase of a rare but serious infection in people who wear soft contact lenses. The infection is Acanthamoeba keratitis, caused by a parasite that is commonly found in nature. It can cause a permanent loss of vision that can.. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=647370 Thu, 31 May 2007 04:00:00 +0100 647370 http://www.medworm.com/index.php?rid=633317&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP040044S001.html The Mynx™ VCS is vascular closure system designed to seal a puncture site in the femoral artery and stop the bleeding after a cardiac catheterization procedure. The Mynx™ VCS uses a balloon catheter and a standard procedural sheath to deliver an... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=633317 Fri, 25 May 2007 04:00:00 +0100 633317 http://www.medworm.com/index.php?rid=633318&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-042707.html Reason for Recall: A small number of clinical laboratories giving the test reported shifts in quality control results. Ortho-Clinical Diagnostics determined that there was a potential for false negative troponin I results at very low levels of troponin... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=633318 Thu, 24 May 2007 04:00:00 +0100 633318 http://www.medworm.com/index.php?rid=630212&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH060001.html The CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System is used with embolic coils for the treatment of intracranial aneurysms. It consists of a self-expanding stent and a delivery system. The stent serves as a scaffold for embolic... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=630212 Tue, 22 May 2007 04:00:00 +0100 630212 http://www.medworm.com/index.php?rid=598425&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH060003.html The Onyx® Liquid Embolic System (Onyx® HD-500) is an artificial material used to block blood flow into aneurysms. The material is used to fill the aneurysm space, or pocket, and prevent the aneurysm from rupturing or increasing in size. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=598425 Mon, 07 May 2007 04:00:00 +0100 598425 http://www.medworm.com/index.php?rid=586542&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frfid%2F Radio Frequency Identification (RFID) is a tool for identifying and tracking items or people. In an RFID system, a small memory-storage chip (tag) is placed on an item. RFID readers (emitters) send out radio waves to detect tags and read their data... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=586542 Thu, 03 May 2007 04:00:00 +0100 586542 http://www.medworm.com/index.php?rid=539252&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp980022s015.html The Paradigm REAL-Time and Guardian REAL-Time Systems are glucose sensors that report glucose values every 5 minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, ages 18... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=539252 Thu, 12 Apr 2007 04:00:00 +0100 539252 http://www.medworm.com/index.php?rid=539251&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp050013.html The device is a glue similar to "Superglue" that is used to closed small skin cuts, lacerations (tears in skin), or surgical incisions (wounds from sharp objects such as a scalpel). (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=539251 Thu, 12 Apr 2007 04:00:00 +0100 539251 http://www.medworm.com/index.php?rid=506584&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Frecalls%2Frecall-011907.html Reason for Recall: The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=506584 Tue, 27 Mar 2007 04:00:00 +0100 506584 http://www.medworm.com/index.php?rid=506583&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH060004.html MESOMARK™ is a laboratory test that is used as an adjunctive test to measure the amount of unique protein fragments (called soluble mesothelin related peptides) in a patient?s blood sample to determine whether a rare cancer of the internal body lining... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=506583 Tue, 27 Mar 2007 04:00:00 +0100 506583 http://www.medworm.com/index.php?rid=506581&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fbreastpumps%2F This site provides general information on breast pumps, medical devices used by a lactating woman to help extract and collect her breast milk. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=506581 Tue, 27 Mar 2007 04:00:00 +0100 506581 http://www.medworm.com/index.php?rid=473360&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmaturityhealthmatters%2F This online newsletter about FDA regulated products for older adults and their caregivers. It focuses on FDA approved products that help people live longer, more productive lives. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=473360 Tue, 13 Mar 2007 04:00:00 +0100 473360 http://www.medworm.com/index.php?rid=473358&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp050053.html INFUSE® Bone Graft is a bone filling material for dental use, and contains a bone protein. It is an alternative to grafting a patient?s own bone. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=473358 Tue, 13 Mar 2007 04:00:00 +0100 473358 http://www.medworm.com/index.php?rid=429176&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060010.html The Spanner™ temporary prostatic stent is a sterile, disposable device, positioned in the prostatic urethra from the bladder neck to the external urinary sphincter. The stent portion of The Spanner™ prevents collapse of the prostatic urethra and allows... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=429176 Wed, 21 Feb 2007 05:00:00 +0100 429176 http://www.medworm.com/index.php?rid=429175&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050025.html This device has two systems: the stent and either of two delivery systems; Over the Wire (OTW), or Monorail® (MR) used with an embolic protection system. The stent is a metal mesh cut from a nitinol folded sheet on a delivery system. The NexStent®... (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=429175 Wed, 21 Feb 2007 05:00:00 +0100 429175 http://www.medworm.com/index.php?rid=429174&cid=s_30475_23_f&fid=30475&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP030047.html The device consists of a stent and delivery catheter system (PRECISE™ OTW Nitinol Stent System) and is used in conjunction with an embolic protection system (ANGIOGUARD™). The stent is a metal mesh tube on a delivery catheter, and the embolic protection.. (Source: CDRH Consumer News) CDRH Consumer News news http://www.medworm.com/rss/comments.php?id=429174 Wed, 21 Feb 2007 05:00:00 +0100 429174