CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

BG3515-5 US BioGlue Surgical Adhesive recalled by CryoLife

CryoLife is recalling BG3515-5 US BioGlue Surgical Adhesive, distributed nationwide in the US. The recall was initiated on 25 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes12MUV034, 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,

Quantity recalled6190 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1674-2014
FDA event ID: 68150
Recalling firm: CryoLife, Kennesaw, GA
Classification: Class II
Status: Terminated
Recall initiated: 25 Apr 2014
FDA classified: 30 May 2014
Reported: 11 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

25 Apr 2014	Recall initiated by company
30 May 2014	Classified by FDA	+35 days
11 Jun 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Serum albumin component monomer failed to meet internally established end of shelf-life specification.

Product as listed by the FDA

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).

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Serum albumin component monomer failed to meet internally established end of shelf-life specification.

Which lots are affected?

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,

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CryoLife

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30 Dec 2020Device	CLASS II	CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife	CryoLife	Device Malfunction	Nationwide
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