Device product
Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1490-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 238
- Official record key
device-enforcement:Z-1490-2016
Official wording
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information: LOTS: SL15175 (150619191) 30-JUN-16 SL15177 (150619191) 30-JUN-16 SL15197 (150719813) 31-JUL-16 SL15199 (150719813) 31-JUL-16 SL15222 (150820354) 31-AUG-16 SL15222 (150820353) 31-AUG-16 SL15224 (150820353) 31-AUG-16 SL15225 (150820354) 31-AUG-16 SL15261 (150920717) 30-SEP-16 SL15261 (150920716) 30-SEP-16 SL15264 (150920716) 30-SEP-16
Distribution pattern: Distributed only in Puerto Rico.
Derived failure modes
-
Manufacturing or process control
inadequate validation/qualification of sterilization processes
-
Sterility assurance
inadequate validation/qualification of sterilization