FDA Device Recalls

Class ITerminated

Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. 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 →

Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.