Device product
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1443-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150
- Official record key
device-enforcement:Z-1443-2016
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 (150619250) 30-JUN-16 SL15180 (150619397) 30-JUN-16 SL15180 (150619396) 30-JUN-16 SL15180 (150619250) 30-JUN-16 SL15202 (150719754) 31-JUL-16 SL15225 (150820263) 31-AUG-16 SL15225 (150820262) 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