—#139068

Product

LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Code:900576A Lots: 140915210 exp. 5/31/15 140915495 exp. 10/31/15 141216351 exp. 12/31/15 141216447 exp. 12/31/15 150116947 exp. 3/31/16 150518827 exp. 5/31/16 150518911 exp. 5/31/16 150519007 exp. 5/31/16 150619186 exp. 6/30/16 150619186 exp. 6/30/16

Why it was recalled

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Root cause (FDA determination)

Packaging

Action the firm took

Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: Distributed Only in Puerto Rico.

Timeline

Recall initiated: 2015-07-10
Posted by FDA: 2015-09-03
Terminated: 2017-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.