Recall Z-0384-2022— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2021-10-07, terminated 2023-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: BioGlue Surgical Adhesive, Model BG3510-5-G. Reason: Product is not approved for use in the EU and should not have been distributed in the EU..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-07
- Terminated
- 2023-10-23
- Firm location
- Kennesaw, GA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.