FDA Device Recalls

Class ITerminated

Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed, Inc

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.

October 8, 2014 · DeviceView details →

Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Higado & Pancrea Pack, Catalog number 900-1966. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

, Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA Device Recalls

Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Hip &#38; Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Higado & Pancrea Pack, Catalog number 900-1966. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

, Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Pack, Catalog number 900-474. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.