—#138994

Product

MINOR PACK 4/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
Affected lot / code info: Code:9002511 Lots: 140412903 exp. 5/31/16 140915507 exp. 10/31/15 141216305 exp. 12/31/15 150116550 exp. 1/31/16 150116549 exp. 1/31/16 150116552 exp. 1/31/16 150116551 exp. 1/31/16 150317840 exp. 4/30/16 150317839 exp. 4/30/16 150317841 exp. 4/30/16 150317841 exp. 4/30/16 150317842 exp. 4/30/16 150317843 exp. 4/30/16 150317844 exp. 4/30/16 150418372 exp. 4/30/16 150418373 exp. 4/30/16 150418374 exp. 4/30/16 150418375 exp. 5/31/16

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 #138994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.