Reported Jun 11, 2014 · Terminated
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to…
CryoLife, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CryoLife, Inc. · 1655 Roberts Blvd NW · Kennesaw, GA · 30144-3632
Is this the product you have?
- 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).
- Lot codes and dates
12MUV03412MUX03512MUV06912MUV03712MUV03812MUV04012MUV04112MUV04212MUV04312MUV04412MUV04512MUV04612MUV04712MUV04812MUV04912MUV05012MUV05112MUV05212MUV05312MUV05412MUV05512MUV05612MUV05712MUV05812MUV05912MUV06012MUV06112MUV06212MUV06312MUV06412MUV06512MUV06712MUV06812MUV06912MUV07012MUV07112MUV07212MUV07312MUV07412MUV07512MUV07613MUV00113MUV00213MUV00313MUV004
- Amount recalled
- 6190 units
Where it was sold
Why it was recalled
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
This product could cause temporary or reversible health problems — stop using it.
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