Other Medical Devices Recalls

O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Urology Pack, Catalog number 900-1521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology.

Teleflex Medical

Class I - Dangerous

Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility of the adaptor.

Sep 3, 2014 Other Medical Devices Nationwide View Details →

Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR

ConMed

Class I - Dangerous

Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

Nov 6, 2014 Other Medical Devices Nationwide View Details →

Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

D&C Laparoscopy Pack, Catalog number 900-1496. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →

Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Oct 8, 2014 Other Medical Devices View Details →