Z-0384-2022 Class II Terminated
FDA device recall Z-0384-2022 was initiated by CryoLife, Inc. on October 7, 2021 and is designated Class II. Reason for recall: Product is not approved for use in the EU and should not have been distributed in the EU. The recall status is terminated (terminated October 23, 2023). Affected quantity: 156 5-pack box units.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- October 7, 2021
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 156 5-pack box units
Product Description
BioGlue Surgical Adhesive, Model BG3510-5-G
Reason for Recall
Product is not approved for use in the EU and should not have been distributed in the EU.
Distribution Pattern
Distribution in the European Union only (Germany/Switzerland)
Code Information
Model BG3510-5-G, Lot BG000255