Device product
FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2566-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1960 kits
- Official record key
device-enforcement:Z-2566-2015
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:9001127 Lots: 150115092 exp. 1/31/16 150115092 exp. 1/31/16 150217549 exp. 2/28/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317666 exp. 4/30/16 150317667 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16 150418282 exp. 4/30/16
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