Device product
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Z-2623-2017
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 77369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 705 single pack boxes
- Official record key
device-enforcement:Z-2623-2017
Official wording
Reason: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Code information: Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
Distribution pattern: Product distributed in Japan.
Derived failure modes
-
Labeling or packaging
incorrectly labeled