Device product
CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Z-2713-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1038
- Official record key
device-enforcement:Z-2713-2015
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: Code: 900944 Lots: 141015772 exp. 10/31/15 141015772 exp. 10/31/15 150116981 exp. 1/31/16 150116827 exp. 2/28/16 150116828 exp. 2/28/16 150116829 exp. 2/28/16 150317866 exp. 4/30/16 150317867 exp. 4/30/16 150317868 exp. 4/30/16 150317869 exp. 4/30/16 150418428 exp. 4/30/16 150418426 exp. 4/30/16 150418427 exp. 4/30/16 150418585 exp. 5/31/16 150418586 exp. 5/31/16 150619298 exp. 6/30/16 150619299 exp. 6/30/16
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