Device product
BioGlue Surgical Adhesive, Model BG3510-5-G
Z-0384-2022
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 88929
- Status
- Terminated
- Classification
- Class II
- Quantity
- 156 5-pack box units
- Official record key
device-enforcement:Z-0384-2022
Official wording
Reason: Product is not approved for use in the EU and should not have been distributed in the EU.
Code information: Model BG3510-5-G, Lot BG000255
Distribution pattern: Distribution in the European Union only (Germany/Switzerland)
Derived failure modes
-
Unknown
Product is not approved for use in the EU and should not have been distributed in the EU.