FDAJune 4, 2018device
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: 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 large vessels (such as aorta, femoral , and carotid arteries).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
What to do
FDA enforcement status: Terminated
Brands named
cryolife
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABioGlue Surgical Adhesive, Model BG3510-5-G2021-10-07
- FDACryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the...2020-11-10
- FDACryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of t...2020-11-10
- FDAOn-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orific...2019-01-17
- FDACryoPatch SG Pulmonary Hemi-Artery, 1 graft2018-09-06
- FDACryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO2018-05-14
- FDACryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP0202018-05-14
- FDABioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J2017-05-19
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