Device product
SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2627-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 540
- Official record key
device-enforcement:Z-2627-2015
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:9002224 Lots: 141015709 exp. 2/28/16 141216301 exp. 12/31/15 150116523 exp. 1/31/16 150116524 exp. 1/31/16 150116525 exp. 1/31/16 150116526 exp. 1/31/16 150317725 exp. 4/30/16 150317726 exp. 4/30/16 150418352 exp. 4/30/16 150418351 exp. 4/30/16 150518686 exp. 5/31/16 150518687 exp. 5/31/16 150519027 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