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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 40.

Deroyal Industries, Inc. Lafollette - Episeal wound closure strips - Class 3 Recall
Sterile wound closure strips, packaged as follows: DeRoyal EPISEAL, Wound Closure Strips, REF 46-202, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal EPISEAL, Wound Closure Strips, REF 46-203, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal EPISEAL, Wound Closure Strips, REF 46-204, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk La...
Source: Medical Device Recalls - April 17, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - PFC Steinman Pin/Drill Pack Sterile (WPC 6672012) - Class 2 Recall
PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made.
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

Abbott Laboratories Inc. - Clinical Chemistry Total Bilirubin - Class 2 Recall
Clinical Chemistry Total Bilirubin, 6L45-20 & 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

KCI USA, Inc. - Zuma Mobility System - Class 2 Recall
Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

Teleflex Medical - Hudson RCI - Class 2 Recall
Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patient s molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube, in the case where one is used.
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

DePuy Orthopaedics, Inc. - DePuy Attune Impaction Handle Warsaw - Class 2 Recall
DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points. Product Usage: The ATTUNE Impaction handle is intended to act as a removable interface for several of the instruments that may be used throughout a procedure. The Attune Impaction Handle is used to impact, insert, and extract various Attune Instruments. The handle interfaces with the Keel Punch, Tibial Tower, Evaluation Bullet, Fixed Bearing Tibial Impactor, Rotating Platform Tibial Impactor and the Femoral Impactor.
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

North Coast Medical Inc - Norco Folding Shower Bench - Class 2 Recall
Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. - Panta Arthrodesis Nail - Class 2 Recall
Panta¿ Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws, two (2) calcaneal screws and one (optional) talar screw. The nail, cross-locking screws and end cap are manufactured from a titanium alloy: TI-6AI-4V ELI ISO 5832-3, ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The Panta¿ Nail is inten...
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

Ziehm Imaging Inc - Double Foot Switch - Class 2 Recall
Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch: Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Stor...
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Beckman Coulter Synchron Ammonia (AMM) Reagent - Class 2 Recall
SYNCHRON Ammonia (AMM) Reagent Product Usage: AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma.
Source: Medical Device Recalls - April 16, 2012 Category: Medical Equipment Source Type: alerts

Scottcare Corporation - TeleSentry, Multiparameter Ambulatory Telemetry - Class 2 Recall
TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.
Source: Medical Device Recalls - April 13, 2012 Category: Medical Equipment Source Type: alerts

MOOG Medical Devices Group - Curlin Infusion Administration Set - Class 2 Recall
Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter ASV Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Source: Medical Device Recalls - April 13, 2012 Category: Medical Equipment Source Type: alerts

Baxa Corporation - Baxa EVA TPN bags - Class 2 Recall
Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
Source: Medical Device Recalls - April 13, 2012 Category: Medical Equipment Source Type: alerts

DeRoyal Industries Inc - Umbilicup - Class 2 Recall
DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
Source: Medical Device Recalls - April 12, 2012 Category: Medical Equipment Source Type: alerts

Spectranetics Corp. - 12Fr SLS II Laser Sheath - Class 2 Recall
12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
Source: Medical Device Recalls - April 11, 2012 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - Boston Scientific, IMAGER II Urology Torque Catheter - Class 2 Recall
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 400-300 Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalog # 400-301 Imager" II Catheters Straight 5fr 65cm M0064003021 M0064003020 Catalog #400-302 Imager" II Catheters Bern 5fr 65cm M0064003031 M0064003030 Catalog #400-303 Imager" II Catheters JB1 5fr 65cm M0064003041 M0...
Source: Medical Device Recalls - April 11, 2012 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - Boston Scientific, IMAGER II Angiographic Catheter, - Class 2 Recall
Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following product is being recalled: "Material Number/(OUTER CARTON LABEL OF 5pk)"/"Material Number (INNER-POUCH LABEL FOR EACH SINGLE CATHETER)" / Material Description / Catalog Number. M001314001 M001314000 IMAGER II/5/ST/65/038 BX5 31-400 M001314011 M001314010 IMAGER II/5/ST/100/038 BX5 31-401 M001314021 M001314020 IMAGER II/5/ST/65/035 BX 5 31-402 M001314031 M001314030 IMAGER II/5/ST/100/035...
Source: Medical Device Recalls - April 11, 2012 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Troponin I STAT Immunoassay - Class 1 Recall
Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
Source: Medical Device Recalls - April 11, 2012 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - Troponin I Immunoassay - Class 1 Recall
Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
Source: Medical Device Recalls - April 11, 2012 Category: Medical Equipment Source Type: alerts

Biocare Medical Llc - Vina Green(tm) Chromogen Kit - Class 2 Recall
BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.
Source: Medical Device Recalls - April 10, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - EasyLink(TM) Informatics Systems - Class 2 Recall
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787
Source: Medical Device Recalls - April 10, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Variseed 7.1 - Class 2 Recall
VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
Source: Medical Device Recalls - April 10, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Axiom Luminos dRF solid state xray imager - Class 2 Recall
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)
Source: Medical Device Recalls - April 9, 2012 Category: Medical Equipment Source Type: alerts

Sendx Medical Inc - SenDx Medical Inc. ABL80FLEX - Class 2 Recall
SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Source: Medical Device Recalls - April 9, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - ADVIA Centaur Cortisol Assay - Class 2 Recall
Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.
Source: Medical Device Recalls - April 9, 2012 Category: Medical Equipment Source Type: alerts

Roche Diagnostics Operations, Inc. - ACCUCHEK Aviva Nano Blood Glucose Meter - Class 2 Recall
ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for...
Source: Medical Device Recalls - April 9, 2012 Category: Medical Equipment Source Type: alerts

Baxa Corporation - ExactaMix 2400(EM2400) Compounder Operating Ststem - Class 2 Recall
Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients
Source: Medical Device Recalls - April 9, 2012 Category: Medical Equipment Source Type: alerts

Beckman Coulter Inc. - Access Immunoassay Systems - Class 2 Recall
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
Source: Medical Device Recalls - April 6, 2012 Category: Medical Equipment Source Type: alerts

Animas Corporation - OneTouch(R) Ping(R) Insulin Pump glucose management system - Class 2 Recall
OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Source: Medical Device Recalls - April 6, 2012 Category: Medical Equipment Source Type: alerts