Device product
Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1479-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144
- Official record key
device-enforcement:Z-1479-2016
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: SL15197 (150719807) 31-JUL-16 SL15240 (150820565) 31-AUG-16 SL15240 (150820339) 31-AUG-16 SL15261 (150920708) 30-SEP-16 SL15261 (150920707) 30-SEP-16 SL15264 (150920707) 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