Device product
OBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2661-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2661-2015
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:9002940 Lots: 140915333 exp. 2/28/19 141116022 exp. 12/31/15 141116022 exp. 12/31/15 150418387 exp. 4/30/16 150418388 exp. 4/30/16 150418497 exp. 4/30/16 150418496 exp. 4/30/16 150518909 exp. 5/31/16 150518910 exp. 5/31/16 150619184 exp. 6/30/16 150619183 exp. 6/30/16 150619183 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