FDA Device recall Z-2623-2017
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- FDA Device
- Class II
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class II recall of BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J by Cryolife, citing the courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2623-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-19 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cryolife |
| Distribution | n/a |
Product
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Reason
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Identifiers
| code_info | Lot Code 17MJX002, Model/Catalog Number BG3510-5-J |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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- BioGlue Surgical Adhesive, Model BG3510-5-G
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2623-2017%22
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