FDA recall Z-0384-2022
CryoLife, Inc. · Class II · device
Product
BioGlue Surgical Adhesive, Model BG3510-5-G
Reason for recall
Product is not approved for use in the EU and should not have been distributed in the EU.
Distribution
Distribution in the European Union only (Germany/Switzerland)
Key facts
- Status
- Terminated
- Initiation date
- 2021-10-07
- Report date
- 2021-12-22
- Termination date
- 2023-10-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kennesaw, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0384-2022