Device product
Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1435-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 938
- Official record key
device-enforcement:Z-1435-2016
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 (150619367) 30-JUN-16 SL15170 (150619366) 30-JUN-16 SL15170 (150619364) 30-JUN-16 SL15170 (150619365) 30-JUN-16 SL15187 (150719668) 31-JUL-16 SL15191-01 (150719669) 31-JUL-16 SL15191-01 (150719670) 31-JUL-16 SL15191-01 (150719667) 31-JUL-16 SL15211 (150720120) 31-JUL-16 SL15211 (150720142) 31-JUL-16 SL15211 (150720122) 31-JUL-16 SL15212 (150720143) 31-JUL-16 SL15212 (150720142) 31-JUL-16 SL15212 (150720121) 31-JUL-16 SL15215 (150720122) 31-JUL-16 SL15215 (150720141) 31-JUL-16 SL15215 (150720121) 31-JUL-16 SL15222 (150720120) 31-JUL-16 SL15233 (150820566) 31-AUG-16 SL15233 (150820568) 31-AUG-16 SL15240 (150820569) 31-AUG-16 SL15243 (150820567) 31-AUG-16 SL15243 (150820566) 31-AUG-16 SL15245 (150820698) 31-AUG-16 SL15245 (150820697) 31-AUG-16 SL15245 (150820696) 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