Z-1405-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2016
- Initiation Date
- January 7, 2016
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4550
Product Description
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.
Reason for Recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Distribution Pattern
Distributed only in Puerto Rico.
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