FDA Device Recalls

Class ITerminated

Gown Surg Fully Impervious Large, Catalog number 900-2564. 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 →

Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Dressing Change, Catalog number 900-1538. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Urology Pack, Catalog number 900-1738. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Cesarean Pack, Catalog number 900-1719. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

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.

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

Surgical Pack, catalog #900-2224 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

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

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

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

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