—#139051

Product

CESAREAN PACK 3/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: OHM — Cesarean Section Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: Code:900403 Lots: 141015707 exp. 10/31/15 141216329 exp. 12/31/15 150116529 exp. 1/31/16 150116530 exp. 1/31/16 150116531 exp. 1/31/16 150116532 exp. 1/31/16 150317799 exp. 3/3/16 150317800 exp. 3/31/16 150317801 exp. 3/31/16 150317802 exp. 4/30/16 150418395 exp. 4/30/16 150418394 exp. 4/30/16 150418396 exp. 4/30/16 150518580 exp. 5/31/16 150518581 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 #139051. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.