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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 20.

Covidien LP - Covidien Duet TRS Loading Unit - Class 2 Recall
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Source: Medical Device Recalls - September 21, 2012 Category: Medical Equipment Source Type: alerts

OPTI Medical Systems, Inc - BP7561 OPTI CCATS BLac Cassette - Class 2 Recall
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
Source: Medical Device Recalls - September 21, 2012 Category: Medical Equipment Source Type: alerts

Custom Medical Specialties, Inc. - PovidineIodine prep solution/Providine prep pads - Class 1 Recall
CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corporation - Head Ring Assembly with Intubation Mounts (HRAIM) - Class 2 Recall
Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corporation - CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL) - Class 2 Recall
Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - SRom Total Hip System Poly Liner - Class 2 Recall
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient m...
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - Surgical Tables - Class 2 Recall
STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard...
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Smith & Nephew Inc - 12/14 TAPER HIGH OFFSET NECK - Class 2 Recall
12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Sekisui Diagnostics Llc - Spectrolyse PAI1 - Class 2 Recall
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Kimberly-Clark Corporation - ULTRA Fabric Reinforced Surgical Gown - Class 3 Recall
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Davol, Inc., Subs. C. R. Bard, Inc. - Bard Ventralight ST Mesh - Class 2 Recall
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - Verify BowieDick Test Card - Class 2 Recall
Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prev...
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Davol, Inc., Subs. C. R. Bard, Inc. - Bard Ventralight ST Mesh - Class 2 Recall
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Kimberly-Clark Corporation - KimberlyClark MIC Safety PEG Kit Pull Type - Class 2 Recall
Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Kimberly-Clark Corporation - KimberlyClark MIC PEG Kit Pull Type - Class 2 Recall
Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Haag-Streit USA Inc - Octopus 101 Perimeter - Class 2 Recall
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Impact Instrumentation, Inc. - Model 324JL OnBoard Suction System - Class 3 Recall
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 21 SX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 15 LX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 13 LX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 15 SX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 18 SX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 18 LX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Asahi Kasei Medical Co., Ltd., Okatomi Plant - Asahi KASEI, REXEED(TM) 25 SX, HEMODIALYZER - Class 2 Recall
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Source: Medical Device Recalls - September 20, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance 16 Slice (Air) - Class 3 Recall
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur systems Calibrator B for FSH - Class 3 Recall
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur systems Calibrator B for Prolactin - Class 3 Recall
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur¿ Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Precise Digital Accelerator - Class 2 Recall
Precise Digital Accelerator Delivery of radiation to defined target volumes
Source: Medical Device Recalls - September 19, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - Amplilink Software v3.2 - Class 2 Recall
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Source: Medical Device Recalls - September 18, 2012 Category: Medical Equipment Source Type: alerts

Bio-Rad Laboratories - MONOLISA ANTIHBs EIA - Class 2 Recall
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or...
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Vascular Solutions, Inc. - Guardian II NC Hemostasis Valve with Guidewire Introducer - Class 2 Recall
Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - Biomet Juggerknot in Guide Punch - Class 2 Recall
JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

BD Biosciences, Systems & Reagents - BD FACS 7color Setup Beads - Class 2 Recall
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

US Endoscopy Group Inc - Infinity sampling device, Cytology Brush - Class 2 Recall
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

ZOLL Medical Corporation - Class 2 Recall
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the moni...
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Steris Corporation - Amsco 3085SP Surgical Table - Class 2 Recall
A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - Empty Evacuated Container 250 mL and 1000 mL. - Class 2 Recall
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Source: Medical Device Recalls - September 17, 2012 Category: Medical Equipment Source Type: alerts

Amsino Medical USA - 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 10 mL in 12 mL Single Use Syringe - Class 3 Recall
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Source: Medical Device Recalls - September 15, 2012 Category: Medical Equipment Source Type: alerts

Amsino Medical USA - 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe - Class 3 Recall
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Source: Medical Device Recalls - September 15, 2012 Category: Medical Equipment Source Type: alerts