FDA Device recall Z-1674-2014
BG3515-5 US 5mL BioGlue Surgical Adhesive
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of BG3515-5 US 5mL BioGlue Surgical Adhesive by Cryolife, citing serum albumin component monomer failed to meet internally established end of shelf-life specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1674-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-25 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cryolife |
| Distribution | US |
Product
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).
Reason
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Identifiers
| code_info | 12MUV034, 12MUX035, 12MUV069, 12MUV037, 12MUV038, 12MUV040, 12MUV041, 12MUV042, 12MUV043, 12MUV044, 12MUV045, 12MUV046,…12MUV034, 12MUX035, 12MUV069, 12MUV037, 12MUV038, 12MUV040, 12MUV041, 12MUV042, 12MUV043, 12MUV044, 12MUV045, 12MUV046, 12MUV047, 12MUV048, 12MUV049, 12MUV050, 12MUV051, 12MUV052, 12MUV053, 12MUV054, 12MUV055, 12MUV056, 12MUV057, 12MUV058, 12MUV059, 12MUV060, 12MUV061, 12MUV062, 12MUV063, 12MUV064, 12MUV065, 12MUV067, 12MUV068, 12MUV069, 12MUV070, 12MUV071, 12MUV072, 12MUV073, 12MUV074, 12MUV075, 12MUV076, 13MUV001, 13MUV002, 13MUV003, 13MUV004, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Cryolife
- BioGlue Surgical Adhesive, Model BG3510-5-G
FDA Device · Class II · 2021-12-22 · Cryolife - CryoPatch SG Pulmonary Human Cardiac Patch
FDA Device · Class II · 2020-12-30 · Cryolife - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · Cryolife - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1674-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.