CryoLife, Inc. Recall 88929
Description: BioGlue Surgical Adhesive, Model BG3510-5-G
CryoLife, Inc. Recall 88929 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0384-2022 |
Event ID | 88929 |
Event Description | BioGlue Surgical Adhesive, Model BG3510-5-G |
Product Type | Devices |
Distribution | Distribution in the European Union only (Germany/Switzerland) |
Quantity | 156 5-pack box units |
Recall Reason | Product is not approved for use in the EU and should not have been distributed in the EU. |
Device Classification | 20211222 |
Device Code Info | Model BG3510-5-G, Lot BG000255 |
Center Classification Date | 20211215 |
Recall Initiation Date | 20211007 |
Recalling Firm | CryoLife, Inc. |
Initial Notification | Letter |
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