Device product
Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1440-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-1440-2016
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: SL15195-01 (150619229) 31-JUL-16 SL15210 (150619392) 31-JUL-16 SL15211 (150619392) 31-JUL-16 SL15223 (150719733) 31-AUG-16 SL15224 (150719733) 31-AUG-16 SL15275 (150920795) 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