Home / Recalls / CryoLife, Inc. / Z-0121-2019

Z-0121-2019 Class II Terminated

Recalled by CryoLife, Inc. — Kennesaw, GA

Recall Details

Product Type
Devices
Report Date
October 24, 2018
Initiation Date
September 6, 2018
Termination Date
March 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 graft

Product Description

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

Reason for Recall

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

Distribution Pattern

US Nationwide in the state of California.

Code Information

Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022

Other recalls by CryoLife, Inc.

  • Z-0384-2022 Class II — BioGlue Surgical Adhesive, Model BG3510-5-G (October 7, 2021)
  • 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-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)