Z-1457-2016 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
- 39
Product Description
Catalog Number: 9002766 SHOULDER PACK 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: SL15184 (150518788) 30-JUN-16 SL15210 (150719844) 31-JUL-16 SL15212 (150719844) 31-JUL-16 SL15243 (150820304) 31-AUG-16 SL15244 (150820304) 31-AUG-16