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 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
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 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
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 ...
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 has...
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 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 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 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: 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 acute...
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 hemodilutio...
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 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 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 wher...
Source: Medical Device Recalls - September 19, 2015 Category: Medical Equipment Source Type: alerts
