Device product
O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2697-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147
- Official record key
device-enforcement:Z-2697-2015
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:900645 Lots: 141015504 exp. 11/30/15 150116817 exp. 2/28/16 150217475 exp. 2/28/16 150217476 exp. 2/28/16 150217477 exp. 2/28/16 150217478 exp. 3/31/16
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