Z-1451-2016 Class II Terminated
FDA device recall Z-1451-2016 was initiated by Customed, Inc on January 7, 2016 and is designated Class II. Reason for recall: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. The recall status is terminated (terminated May 3, 2017). Affected quantity: 76.
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
- 76
Product Description
Catalog Number: 9002516 LAPAROTOMY SURGICAL 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: SL15203 (150719261) 31-JUL-16 SL15203 (150719842) 31-JUL-16 SL15211 (150719261) 31-JUL-16 SL15211 (150719842) 31-JUL-16 SL15244 (150820297) 31-AUG-16 SL15245 (150820297) 31-AUG-16