Reported Jul 5, 2017 · Terminated

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

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 Surgical Adhesive, Model/Catalog Number BG3510-5-J
Lot codes and dates
    • Lot Code 17MJX002
    • Model/Catalog Number BG3510-5-J
Amount recalled
705 single pack boxes

Why it was recalled

The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 8, 2019 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.