—#138857

Product

MAJOR LAPAROTOMY PK 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
510(k) numbers: K902031
Affected lot / code info: Catalog number:900036 Lots: 141015515 exp. 11/30/15 141015515 exp. 11/30/15 141216311 exp. 12/31/15 150116932 exp. 1/31/16 150116931 exp. 1/31/16 150116935 exp. 1/31/16 150116934 exp. 1/31/16 150116933 exp. 1/31/16 150217245 exp. 1/31/16 150217246 exp. 1/31/16 150217247 exp. 1/31/16 150317571 exp. 3/31/16 150317572 exp. 3/31/16 150317573 exp. 3/31/16 150317575 exp. 4/30/16 150317574 exp. 4/30/16 150418256 exp. 4/30/16 150418256 exp. 4/30/16 150418257 exp. 4/30/16 150418258 exp. 4/30/16 150418259 exp. 4/30/16 150518615 exp. 5/31/16 150518616 exp. 5/31/16 150518616 exp. 5/31/16 150519020 exp. 5/31/16 150519019 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 #138857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.