Reported Aug 1, 2018 · Terminated
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard…
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?
- BioGlue Spreader Tip, 12mm, Sterile, RX Only
- Product UsageBioGlue 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)
- Lot codes and dates
Model Number BG3510-5-JLot Number 18MJX002
- Amount recalled
- 855 Total
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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