Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8) - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenou...
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8) - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally markete...
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration set...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration set...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration se...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration se...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Sigma Spectrum Infusion Pump with master Drug Library Version 6. - Class 2 Recall
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts

Terumo Cardiovascular Systems Corp - Cardiovascular Procedure Kits, Tubing Pack - Class 2 Recall
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ ...
Source: Medical Device Recalls - April 7, 2018 Category: Medical Devices Source Type: alerts

CUPRESSUS LAWSONIANA (Chamaecyparis Lawsoniana Fruiting Twig) Liquid [Washington Homeopathic Products]
Updated Date: Dec 28, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 28, 2017 Category: Drugs & Pharmacology Source Type: alerts

CUPRESSUS LAWSONIANA (Chamaecyparis Lawsoniana Fruiting Twig) Pellet [Washington Homeopathic Products]
Updated Date: May 23, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 23, 2017 Category: Drugs & Pharmacology Source Type: alerts

Becton Dickinson & Company - BD - Class 2 Recall
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 2, 2017 Category: Medical Equipment Source Type: alerts

Angiodynamics Inc. (Navilyst Medical Inc.) - Celerity PICC Tip Confirmation System - Class 2 Recall
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity Syste...
Source: Medical Device Recalls - February 4, 2017 Category: Medical Equipment Source Type: alerts

Howmedica Osteonics Corp. - Stryker AccuLIF PL Cages - Class 2 Recall
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerati...
Source: Medical Device Recalls - September 13, 2016 Category: Medical Equipment Source Type: alerts

Howmedica Osteonics Corp. - Stryker AccuLIF PL Cages - Class 2 Recall
AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerat...
Source: Medical Device Recalls - September 13, 2016 Category: Medical Equipment Source Type: alerts

Howmedica Osteonics Corp. - Stryker AccuLIF PL Cages - Class 2 Recall
AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerativ...
Source: Medical Device Recalls - September 13, 2016 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Custom Cardiovascular Kits - Class 2 Recall
Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications f...
Source: Medical Device Recalls - September 1, 2016 Category: Medical Equipment Source Type: alerts

EDP HENNA (Lawsonia Inermis Leaf) Powder [EDP Inc.]
Updated Date: Jun 27, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 27, 2016 Category: Drugs & Pharmacology Source Type: alerts

EDP HENNA (Lawsonia Inermis Leaf) Powder [TRYBEST Inc.]
Updated Date: Feb 2, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 2, 2016 Category: Drugs & Pharmacology Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Procedure Kit - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution h...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute ...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acut...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acut...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Procedure Kit - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilut...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute ...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corp - Terumo Cardiovascular Systems (CVS) - Class 2 Recall
Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures wh...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts

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 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

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 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 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

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 treatment ...
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. (Sour...
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