Home / Recalls / CryoLife, Inc. / Z-2271-2018

Z-2271-2018 Class II Terminated

Recalled by CryoLife, Inc. — Kennesaw, GA

Recall Details

Product Type
Devices
Report Date
June 27, 2018
Initiation Date
May 14, 2018
Termination Date
March 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

Reason for Recall

Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

Distribution Pattern

AR, OH

Code Information

Serial Number 10988203

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-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-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)