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BioGlue Surgical Adhesive
Artivion, Inc. · Model BGAT-27-SY · UDI-DI 00877234000171
MUQ
Prescription
0
510(k) clearances
495
Adverse events (45 deaths)
5
Recalls
6
Facilities
Description
BioGlue Surgical Adhesive Syringe Extender Tips
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-10-07 | CryoLife, Inc. | Product is not approved for use in the EU and should not have been distributed in the EU. |
| 2021-10-05 | Siemens Medical Solutions USA, Inc | System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more th |
| 2018-06-04 | CryoLife, Inc. | The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouche |
| 2017-05-19 | CryoLife, Inc. | The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. |
| 2014-04-25 | CryoLife, Inc. | Serum albumin component monomer failed to meet internally established end of shelf-life specification. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.