Z-2623-2017 Class II Terminated
FDA device recall Z-2623-2017 was initiated by CryoLife, Inc. on May 19, 2017 and is designated Class II. Reason for recall: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. The recall status is terminated (terminated February 8, 2019). Affected quantity: 705 single pack boxes.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 19, 2017
- Termination Date
- February 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 705 single pack boxes
Product Description
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Reason for Recall
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Distribution Pattern
Product distributed in Japan.
Code Information
Lot Code 17MJX002, Model/Catalog Number BG3510-5-J