Recall Z-1674-2014— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2014-04-25, terminated 2014-11-10. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-25
- Terminated
- 2014-11-10
- Firm location
- Kennesaw, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.