Device product
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1431-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55
- Official record key
device-enforcement:Z-1431-2016
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: SL15177 (150619358) 30-JUN-16 SL15191-01 (150619359) 31-JUL-16 SL15211 (150719661) 31-JUL-16 SL15217 (150719661) 31-JUL-16 SL15245 (150720128) 31-AUG-16 SL15245 (150720127) 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