Device product
O.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2694-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300
- Official record key
device-enforcement:Z-2694-2015
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:900629 Lots: 150116616 exp. 1/31/16 150116615 exp. 1/31/16 150116614 exp. 1/31/16 150116986 exp. 1/31/16 141216355 exp. 3/31/16 150318007 exp. 4/30/16 150318008 exp. 4/30/16 150318009 exp. 4/30/15 150519013 exp. 5/31/16 150619291 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