CDRH Consumer News
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173 records returned
Class I Medical Device Recall: Draeger Medical Inc., Stabilet Infant Warmer
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Reason for Recall: These out-of-date devices may cause serious injury to infants or caregivers. (Source: CDRH Consumer News)
Source: CDRH Consumer News - August 25, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Luv N' Care Gel-Filled Teethers - 'Nuby,' 'Cottontails,' and 'Playschool'Email this article to a colleague.
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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)
Source: CDRH Consumer News - August 12, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: Sculptra Aesthetic - P030050S002Email this article to a colleague.
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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)
Source: CDRH Consumer News - August 6, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Abbott Vascular-Cardiac Therapies dba Guidant Corporation, POWERSAIL Coronary Dilatation CathetersEmail this article to a colleague.
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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)
Source: CDRH Consumer News - August 6, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Cardinal Health, Various Modules of the Alaris SystemEmail this article to a colleague.
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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)
Source: CDRH Consumer News - August 5, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: TAXUS® Liberte? Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008S011Email this article to a colleague.
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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)
Source: CDRH Consumer News - August 4, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Medtronic MiniMed Paradigm Quick-Set Infusion SetsEmail this article to a colleague.
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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)
Source: CDRH Consumer News - July 21, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Respironics California Inc., BiPAP Focus Non-Invasive Ventilator SystemEmail this article to a colleague.
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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)
Source: CDRH Consumer News - July 9, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: TAXUS® Liberté® Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems) - P060008/S008Email this article to a colleague.
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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)
Source: CDRH Consumer News - June 29, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Medtronic Inc., Kappa 600/700/900 Series of Pacemakers and Sigma 100/200/300 Series of PacemakersEmail this article to a colleague.
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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)
Source: CDRH Consumer News - June 12, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: BRYAN® Cervical Disc - P060023Email this article to a colleague.
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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)
Source: CDRH Consumer News - May 27, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003)Email this article to a colleague.
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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)
Source: CDRH Consumer News - May 18, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: REPEL-CV® Bioresorbable Adhesion Barrier - P070005Email this article to a colleague.
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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)
Source: CDRH Consumer News - May 7, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Biosite Incorporated, Triage Cardiac PanelEmail this article to a colleague.
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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)
Source: CDRH Consumer News - May 7, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: Medtronic® Attain Ability? Model 4196 Lead - P080006Email this article to a colleague.
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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)
Source: CDRH Consumer News - April 17, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: ARCHITECT® CORE Reagent Kit, Calibrator and Controls - P080023Email this article to a colleague.
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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)
Source: CDRH Consumer News - April 17, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Teleflex Medical, Arrow International Inc. 30, 40, and 50 cc Intra-Aortic BalloonsEmail this article to a colleague.
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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)
Source: CDRH Consumer News - April 15, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: Synvisc-One (hylan GF-20) - P940015S012Email this article to a colleague.
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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)
Source: CDRH Consumer News - April 13, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: FC2 Female Condom - P080002Email this article to a colleague.
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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)
Source: CDRH Consumer News - April 13, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: CervistaTM HPV HR and GenfindTM DNA Extraction Kit - P080014Email this article to a colleague.
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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)
Source: CDRH Consumer News - April 13, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: Cervista? HPV 16/18 - P080015Email this article to a colleague.
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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)
Source: CDRH Consumer News - April 13, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: ZOLL Medical Corporation, ZOLL AED Plus DefibrillatorEmail this article to a colleague.
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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)
Source: CDRH Consumer News - April 8, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Tri-State Hospital Supply Corporation - Centurion Trays and KitsEmail this article to a colleague.
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Reason for Recall: The weak package sealing may affect the sterility of the devices. (Source: CDRH Consumer News)
Source: CDRH Consumer News - April 3, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Tri-State Hospital Supply Corporation - Multiple Trays and KitsEmail this article to a colleague.
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Reason for Recall: The weak package sealing may affect the sterility of the devices. (Source: CDRH Consumer News)
Source: CDRH Consumer News - April 3, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlideEmail this article to a colleague.
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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)
Source: CDRH Consumer News - March 27, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AEDEmail this article to a colleague.
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The device may experience: Low defibrillation energy delivery, Unexpected device shutdown, and/or Inadequate filtering of electromagnetic noise. (Source: CDRH Consumer News)
Source: CDRH Consumer News - March 16, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion PumpsEmail this article to a colleague.
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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)
Source: CDRH Consumer News - March 11, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: XACT® Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens - P080021Email this article to a colleague.
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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)
Source: CDRH Consumer News - March 9, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: NAVISTAR® THERMOCOOL® and EZ Steer THERMOCOOL® Nav Irrigated Deflectable Diagnostic/Ablation Catheter for Treatment of Paroxysmal Atrial Fibrillation - P030031S011Email this article to a colleague.
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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)
Source: CDRH Consumer News - March 9, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: LifeStent FlexStar and FlexStar XL Vascular Stent - P070014Email this article to a colleague.
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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)
Source: CDRH Consumer News - March 9, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy TubeEmail this article to a colleague.
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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)
Source: CDRH Consumer News - March 9, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: Reclaim? DBS? Therapy for OCD - H050003Email this article to a colleague.
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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)
Source: CDRH Consumer News - March 3, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: TECNIS® Multifocal Foldable Silicone and Acrylic Intraocular Lenses - P080010Email this article to a colleague.
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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)
Source: CDRH Consumer News - January 30, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: Express® SD Renal Monorail® Premounted Stent System - P060006Email this article to a colleague.
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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)
Source: CDRH Consumer News - January 28, 2009 Category: Medical Equipment Source Type: news
Consumer Information on: BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear - P080011Email this article to a colleague.
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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)
Source: CDRH Consumer News - January 28, 2009 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Stryker Leibinger USA., Stryker Custom Cranial Implant KitsEmail this article to a colleague.
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Reason for Recall: The company is recalling these products because sterility cannot be assured. (Source: CDRH Consumer News)
Source: CDRH Consumer News - December 24, 2008 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Sun Med Greenline/D MacIntosh No. 3 Laryngoscope BladesEmail this article to a colleague.
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A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure. (Source: CDRH Consumer News)
Source: CDRH Consumer News - December 19, 2008 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Integra NeuroSciences, Gravity Compensating AccessoryEmail this article to a colleague.
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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)
Source: CDRH Consumer News - December 11, 2008 Category: Medical Equipment Source Type: news
Consumer Information on: E-LUMINEXX Vascular Stent - P080007Email this article to a colleague.
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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)
Source: CDRH Consumer News - December 11, 2008 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD)Email this article to a colleague.
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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)
Source: CDRH Consumer News - December 10, 2008 Category: Medical Equipment Source Type: news
Report to Congress: Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin DamageEmail this article to a colleague.
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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)
Source: CDRH Consumer News - December 5, 2008 Category: Medical Equipment Source Type: news
Consumer Information on: COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer - P060030Email this article to a colleague.
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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)
Source: CDRH Consumer News - November 26, 2008 Category: Medical Equipment Source Type: news
Consumer Information on: Helios II Ablation Catheter - P050029Email this article to a colleague.
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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)
Source: CDRH Consumer News - November 21, 2008 Category: Medical Equipment Source Type: news
Consumer Information on: Carotid WALLSTENT® Monorail® Endoprosthesis - P050019Email this article to a colleague.
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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)
Source: CDRH Consumer News - November 21, 2008 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin PumpEmail this article to a colleague.
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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)
Source: CDRH Consumer News - November 20, 2008 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-GaugeEmail this article to a colleague.
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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)
Source: CDRH Consumer News - November 6, 2008 Category: Medical Equipment Source Type: news
Class I Medical Device Recall: VIBE Technologies, Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Field GeneratorEmail this article to a colleague.
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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)
Source: CDRH Consumer News - October 31, 2008 Category: Medical Equipment Source Type: news
Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary IncontinenceEmail this article to a colleague.
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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)
Source: CDRH Consumer News - October 21, 2008 Category: Medical Equipment Source Type: news
Information on Surgical Mesh for Hernia RepairsEmail this article to a colleague.
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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)
Source: CDRH Consumer News - October 21, 2008 Category: Medical Equipment Source Type: news
