Home / Recalls / CryoLife, Inc. / Z-0384-2022

Z-0384-2022 Class II Terminated

Recalled by CryoLife, Inc. — Kennesaw, GA

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

Other recalls by CryoLife, Inc.

  • Z-0653-2021 Class II — CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tis (November 10, 2020)
  • Z-0652-2021 Class II — CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissu (November 10, 2020)
  • Z-1073-2019 Class II — On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Pr (January 17, 2019)
  • Z-0121-2019 Class II — CryoPatch SG Pulmonary Hemi-Artery, 1 graft (September 6, 2018)
  • Z-2556-2018 Class II — BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indi (June 4, 2018)
  • Z-2271-2018 Class II — Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO (May 14, 2018)
  • Z-2272-2018 Class II — Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 (May 14, 2018)
  • Z-2623-2017 Class II — BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J (May 19, 2017)
  • Z-1219-2019 Class II — CryoPatch SG Pulmonary Hemi-Artery Patch (November 21, 2016)
  • Z-2715-2017 Class II — On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of (June 12, 2015)