Device product
Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1491-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 576
- Official record key
device-enforcement:Z-1491-2016
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: SL15180 (150619377) 30-JUN-16 SL15184 (150619377) 30-JUN-16 SL15229 (150619378) 31-AUG-16 SL15230 (150819814) 31-AUG-16 SL15231 (150820356) 31-AUG-16 SL15231 (150819816) 31-AUG-16 SL15231 (150819815) 31-AUG-16 SL15259 (150920355) 30-SEP-16 SL15261 (150920357) 30-SEP-16 SL15266 (150920358) 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