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CryoLife, Inc. Recall 88929

Description: BioGlue Surgical Adhesive, Model BG3510-5-G

CryoLife, Inc. Recall 88929 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0384-2022
Event ID88929
Event DescriptionBioGlue Surgical Adhesive, Model BG3510-5-G
Product TypeDevices
DistributionDistribution in the European Union only (Germany/Switzerland)
Quantity156 5-pack box units
Recall ReasonProduct is not approved for use in the EU and should not have been distributed in the EU.
Device Classification20211222
Device Code InfoModel BG3510-5-G, Lot BG000255
Center Classification Date20211215
Recall Initiation Date20211007
Recalling FirmCryoLife, Inc.
Initial Notification Letter
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