Device product
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-2551-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4800 trays
- Official record key
device-enforcement:Z-2551-2015
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: Catalog number:900020 Lots: 150116955 exp. 1/31/16 150116713 exp. 1/31/16 150317568 exp. 2/28/16 150317568 exp. 2/28/16 150418231 exp. 4/30/16 150418231 exp. 4/30/16 150518598 exp. 5/31/16
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