FDA Device Recalls

Class ITerminated

Laparoscopy Chole Pack, Catalog number 900-2004. 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 →

Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Chole Pack, Catalog number 900-2004. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Urology Pack, Catalog number 900-1742. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Cesarean Pack, Catalog # 900-851 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.