Device product
UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2592-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 352
- Official record key
device-enforcement:Z-2592-2015
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:9001521 Lots: 141015699 exp. 11/30/15 141115980 exp. 12/31/15 150116560 exp. 2/28/16 150116560 exp. 2/28/16 150217271 exp. 2/28/16 150317613 exp. 4/30/16 150317616 exp. 4/30/16 150317615 exp. 4/30/16 150518646 exp. 5/31/16 150418301 exp. 5/31/16 150518647 exp. 5/31/16 150418302 exp. 5/31/16 150619387 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