Device product
Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1450-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 344
- Official record key
device-enforcement:Z-1450-2016
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: SL15170 (150317841) 30-APR-16 SL15170 (150317843) 30-APR-16 SL15180 (150619260) 30-JUN-16 SL15184 (150317844) 30-APR-16 SL15199 (150719841) 31-JUL-16 SL15203 (150719841) 31-JUL-16 SL15229 (150820295) 31-AUG-16 SL15245 (150820296) 31-AUG-16 SL15246 (150820296) 31-AUG-16 SL15267 (150920885) 31-AUG-16 SL15268 (150920886) 31-AUG-16 SL15271 (150920887) 31-AUG-16 SL15273 (150920884) 31-AUG-16 SL15273 (150920809) 31-AUG-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