Device product
HIGADO Y PANCREA 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2616-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248
- Official record key
device-enforcement:Z-2616-2015
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:9001966 Lots: 141015750 exp. 11/30/15 140814976 exp. 10/31/15 141216318 exp. 1/31/16 150317708 exp. 4/30/16 150317709 exp. 4/30/16 150418331 exp. 4/30/16 150418332 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