Recalls / —
—#138881
Product
OPEN HEART TRAY 1/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
- OFA — Cardiovascular Surgical Instruments Tray
- Device class
- Class 1
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Code:9001196C Lots: 141015478 exp. 10/31/15 141115954 exp. 11/30/15 150318096 exp. 3/31/16 150418443 exp. 4/30/16 150418590 exp. 4/30/16 150518901 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 #138881. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.