Recall Z-2623-2017 ยท MUQ Glue, Surgical, Arteries
CryoLife, Inc.
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
| Date | May 19, 2017 |
| Status | Terminated |
| Reason | The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. |
| Root cause | Labeling mix-ups |
| Action | Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped. |
| Quantity | 705 single pack boxes |
| Distribution | Product distributed in Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.