Device product
Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1438-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168
- Official record key
device-enforcement:Z-1438-2016
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: SL15169 (150518594) 30-JUN-16 SL15170 (150518592) 30-JUN-16 SL15199 (150719720) 30-JUN-16 SL15199 (150719719) 30-JUN-16 SL15203 (150719720) 30-JUN-16 SL15230 (150819721) 30-JUN-16 SL15231 (150819722) 30-JUN-16 SL15231 (150820230) 30-JUN-16 SL15243 (150820231) 30-JUN-16 SL15243 (150820229) 30-JUN-16 SL15259 (150920791) 30-JUN-16 SL15259 (150920917) 30-JUN-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