Z-1674-2014Class II

BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an...

Name: Z-1674-2014 BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an...
Creator: CryoLife, Inc.
Published: 2014-04-25
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2014-04-25 / Terminated / root cause: manufacturing process

FDA source

CryoLife, Inc. began a recall of BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis... on 2014-04-25. FDA classified it as Class II and gives the reason as "Serum albumin component monomer failed to meet internally established end of shelf-life specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1674-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Posted: 2014-05-30
Terminated: 2014-11-10
Recalling firm: Artivion, Inc.
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).
Product code: MUQ Glue, Surgical, Arteries
Reason for recall: Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All consignees were notified of the voluntary actions by issuance of Field Correction/Removal Notice on April 24, 2014. This notices states which lot numbers are to be returned, and which lot numbers can be relabeled with a corrected expiration date.
Quantity in commerce: 6190 units
Distribution: Distributed Nationwide including Puerto Rico and the states of AL, AK,AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM , NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-05-30

Product code MUQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)