Device product
Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1405-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4550
- Official record key
device-enforcement:Z-1405-2016
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: LOTS: SL15169 (150317576) 28-FEB-16 SL15169 (150619102) 31-MAY-16 SL15169 (150518600) 31-MAY-16 SL15170 (150518600) 31-MAY-16 SL15173 (150619102) 31-MAY-16 SL15175 (150418229) 31-MAY-16 SL15199 (150719614) 31-MAY-16 SL15203 (150719614) 31-MAY-16 SL15225 (150719614) 31-MAY-16 SL15231 (150820140) 31-AUG-16 SL15243 (150820140) 31-AUG-16 SL15251 (150820140) 31-AUG-16 SL15272 (150920663) 30-SEP-16 SL15273 (150920663) 30-SEP-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