BioGlue Surgical Adhesive, Model BG3510-5-G
This recall has been terminated (originally issued October 7, 2021).
- Company
- Cryolife Inc
- Recall Initiated
- October 7, 2021
- Terminated
- October 23, 2023
- Recall Number
- Z-0384-2022
- Quantity
- 156 5-pack box units
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Product is not approved for use in the EU and should not have been distributed in the EU.
Distribution
Distribution in the European Union only (Germany/Switzerland)
Lot / Code Info
Model BG3510-5-G, Lot BG000255
Root Cause
No Marketing Application
Action Taken
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.
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