Glue, Surgical, Arteries
FDA product code MUQ · Class III (high risk) · Cardiovascular
0510(k) clearances
1PMA approvals
5recalls
Implantimplanted device
PMA approvals
- P010003 Bioglue Surgical Adhesive · Cryolife, Inc. · 12/03/2001
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0384-2022 Class II | BioGlue Surgical Adhesive, Model BG3510-5-GProduct is not approved for use in the EU and should not have been distributed in the EU. | CryoLife, Inc. | 10/07/2021Terminated |
| Z-0226-2022 Class II | Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2)…System operator manual states that the system should be rebooted once, every 7 days. In some cases, users… | Siemens Medical Solutions USA, Inc | 10/05/2021Open, Classified |
| Z-2556-2018 Class II | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for…The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly… | CryoLife, Inc. | 06/04/2018Terminated |
| Z-2623-2017 Class II | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-JThe courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. | CryoLife, Inc. | 05/19/2017Terminated |
| Z-1674-2014 Class II | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is…Serum albumin component monomer failed to meet internally established end of shelf-life specification. | CryoLife, Inc. | 04/25/2014Terminated |