Device product
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Z-2712-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 874
- Official record key
device-enforcement:Z-2712-2015
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: 900921A Lots: 141015499 exp. 3/31/16 141216451 exp. 1/31/16 141216364 exp. 12/31/15 150317861 exp. 3/31/16 150317860 exp. 3/31/16 150418472 exp. 4/30/16 150418473 exp. 4/30/16 150518583 exp. 5/31/16 150518584 exp. 5/31/16 150518913 exp. 5/31/16 150619191 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