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).
Reported: June 11, 2014 Initiated: April 25, 2014 #Z-1674-2014
Product Description
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 for Recall
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Details
- Recalling Firm
- CryoLife, Inc.
- Units Affected
- 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.
- Location
- Kennesaw, GA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by CryoLife, Inc.. Units affected: 6190 units.
Why was this product recalled? ▼
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1674-2014.
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