Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2623-2017 — BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

U.S. FDA — Device Enforcement · United States · 2017-05-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2623-2017
Date of alert
2017-05-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CryoLife, Inc.
Product category
device
Product type
Devices
Reported risk: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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