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Terminated

BioGlue Surgical Adhesive, Model BG3510-5-G

FDA Recall Z-0384-2022 · Posted None

Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMUQ
Date Initiated2021-10-07
Date Terminated2023-10-23
Product Quantity156 5-pack box units

Reason for Recall

Product is not approved for use in the EU and should not have been distributed in the EU.

Firm Action

A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm.

Root Cause

No Marketing Application

Distribution Pattern

Distribution in the European Union only (Germany/Switzerland)

Official Source

View FDA Recall →

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

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