CareFusion 203, Inc. - The EnVe/ ReVel Ventilator - Class 1 Recall
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - Disposable StrykeFlow Tips - Class 2 Recall
Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Endoscopy 5900 Optical Court San Jose, CA .Stryker s Suction Irrigation system is used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. This product line includes pumps, attachment tips, accessories and adaptors. A number of reusable, deposable (20 uses) and disposable tips of varying lengths, diameters, and tip styles may be used with Stryker s Suction Irrigation system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2014 Category: Medical Equipment Source Type: alerts
Merit Medical Systems, Inc. - Merit Custom Syringe Kit - Class 2 Recall
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010, Sterile EO, 15 Units Product Usage: Merit Medical Custom Syringe Kit is a combination of legally marketed medical devices into container(s) for the convenience of the user and within the limits of their original intended use. Syringes are used to inject fluids, or withdraw fluids from the body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 4, 2014 Category: Medical Equipment Source Type: alerts
Merit Medical Systems, Inc. - Merit Medical's Custom Procedural Trays - Class 1 Recall
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2014 Category: Medical Equipment Source Type: alerts
RTI Surgical, Inc. - OPTEFORM Allograft Paste - Class 2 Recall
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 8, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - REF BLACKMAXNSwivel/Angle Motor Assembly - Class 2 Recall
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - REF IMRIMOTORiMRI Handpiece - Class 2 Recall
***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - REF XMAXXMax Handpiece - Class 2 Recall
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126** Intended for cutting and shaping bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2014 Category: Medical Equipment Source Type: alerts
The Anspach Effort, Inc. - REF MICROMAXmicroMax Handpiece - Class 2 Recall
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** Intended for cutting and shaping bone. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2014 Category: Medical Equipment Source Type: alerts
Stryker Spine - Stryker Spine Torque Wrench - Class 2 Recall
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the...
Source: Medical Device Recalls - November 22, 2013 Category: Medical Equipment Source Type: alerts
Merit Medical Systems, Inc. - Custom Procedural Trays - Class 2 Recall
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient. (Source: Me...
Source: Medical Device Recalls - July 4, 2013 Category: Medical Equipment Source Type: alerts
Merit Medical Systems, Inc. - Merit Medical's Custom Procedural Tray - Class 2 Recall
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F. Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2013 Category: Medical Equipment Source Type: alerts
