Home / Recalls / CryoLife, Inc. / Z-1219-2019

Z-1219-2019 Class II Terminated

Recalled by CryoLife, Inc. — Kennesaw, GA

Recall Details

Product Type
Devices
Report Date
May 1, 2019
Initiation Date
November 21, 2016
Termination Date
September 24, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

CryoPatch SG Pulmonary Hemi-Artery Patch

Reason for Recall

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

Distribution Pattern

Product was shipped to Texas

Code Information

Model #: SGPHOO Serial #10685466

Other recalls by CryoLife, Inc.

  • Z-0384-2022 Class II — BioGlue Surgical Adhesive, Model BG3510-5-G (October 7, 2021)
  • Z-0652-2021 Class II — CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissu (November 10, 2020)
  • Z-0653-2021 Class II — CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tis (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-2715-2017 Class II — On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of (June 12, 2015)