Recalls / —
—#143393
Product
Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- FDA product code
- OKV — Obstetrical Kit
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- 510(k) numbers
- K902032
- Affected lot / code info
- LOTS: SL15169 (150619380) 30-JUN-16 SL15174 (150619380) 30-JUN-16 SL15201-01 (150719634) 31-JUL-16 SL15212 (150720070) 31-JUL-16 SL15212 (150720071) 31-JUL-16 SL15272 (150920769) 30-SEP-16 SL15273 (150920769) 30-SEP-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
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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
- 2016-01-07
- Posted by FDA
- 2016-04-14
- Terminated
- 2017-05-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #143393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.