Recall Z-0384-2022 ยท MUQ Glue, Surgical, Arteries
CryoLife, Inc.
BioGlue Surgical Adhesive, Model BG3510-5-G
| Date | Oct 7, 2021 |
| Status | Terminated |
| Reason | Product is not approved for use in the EU and should not have been distributed in the EU. |
| Root cause | No Marketing Application |
| Action | A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm. |
| Quantity | 156 5-pack box units |
| Distribution | Distribution in the European Union only (Germany/Switzerland) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.