—#138958

Product

LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K902031
Affected lot / code info: Code:900176 Lots: 141216310 exp. 12/31/15 150116977 exp. 1/31/16 150116977 exp. 1/31/16 150116775 exp. 1/31/16 150116772 exp. 1/31/16 150116774 exp. 1/31/16 150116773 exp. 1/31/16 150317694 exp. 3/31/16 150317695 exp. 3/31/16 150317696 exp. 3/31/16 150317697 exp. 3/31/16 150317698 exp. 3/31/16 150317693 exp. 3/31/16 150418316 exp. 4/30/16 150418317 exp. 4/30/16 150418578 exp. 4/30/16 150418579 exp. 4/30/16 150519009 exp. 5/31/16 150619364 exp. 6/30/16 150619365 exp. 6/30/16 150619366 exp. 6/30/16 150619367 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 #138958. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.