—#138874

Product

FOLEY CATHETER KIT II 16FR. CUSTOMED 20/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: NWR
510(k) numbers: K962652
Affected lot / code info: Code:9001127 Lots: 150115092 exp. 1/31/16 150115092 exp. 1/31/16 150217549 exp. 2/28/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317667 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16

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 #138874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.