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Terminated

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

FDA Recall Z-2623-2017 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMUQ
Date Initiated2017-05-19
Date Terminated2019-02-08
Product Quantity705 single pack boxes

Reason for Recall

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

Firm Action

Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.

Root Cause

Labeling mix-ups

Distribution Pattern

Product distributed in Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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