Device product
CESAREAN PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2674-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 490
- Official record key
device-enforcement:Z-2674-2015
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:900410 Lots: 141015763 exp. 10/31/15 140814986 exp. 10/31/15 141216332 exp. 12/31/15 141216332 exp. 12/31/15 150116562 exp. 1/31/16 150317651 exp. 3/31/16 150317975 exp. 3/31/16 150317978 exp. 3/31/16 150317976 exp. 4/30/16 150317977 exp. 4/30/15 150518814 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