Device product
LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2677-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300
- Official record key
device-enforcement:Z-2677-2015
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:900419 Lots: 140613836 exp. 1/31/16 140814953 exp. 10/31/15 150116537 exp. 1/31/16 150116535 exp. 1/31/16 141216339 exp. 12/31/15 141216339 exp. 12/31/15 150418410 exp. 4/30/16 150418411 exp. 4/30/16 150518802 exp. 5/31/16 150518802 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