Z-1076-2015 Class II Terminated
FDA device recall Z-1076-2015 was initiated by MAST Biosurgery USA, Inc on August 26, 2014 and is designated Class II. Reason for recall: The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July… The recall status is terminated (terminated February 24, 2015). Affected quantity: 49 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2015
- Initiation Date
- August 26, 2014
- Termination Date
- February 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 pieces
Product Description
The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.
Reason for Recall
The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017.
Distribution Pattern
Worldwide Distribution to the country of China.
Code Information
LOT 52804 2017-08