Recalls / —
—#138872
Product
PERY GYN PACK CUSTOMED 10/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
- OHD — Gynecological Laparoscopic Kit
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- Affected lot / code info
- Code:9001091 Lots: 141015789 exp. 5/31/19 141115972 exp. 12/31/15 150116985 exp. 1/31/16 150217441 exp. 2/28/16 150217442 exp. 2/28/16 150418281 exp. 4/30/16 150518223 exp. 5/31/16 150519018 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 #138872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.