FDA-Device2017-07-05Class II
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
CryoLife, Inc.
Hazard
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Sold states
Product distributed in Japan.
Affected count
705 single pack boxes
Manufactured in
1655 Roberts Blvd NW, N/A, Kennesaw, GA, United States
Products
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2623-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief