Home / Recalls / CryoLife, Inc. / Z-0809-2014

Z-0809-2014 Class II Terminated

Recalled by CryoLife, Inc. — Kennesaw, GA

Recall Details

Product Type
Devices
Report Date
January 29, 2014
Initiation Date
November 22, 2013
Termination Date
February 20, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
One

Product Description

Pulmonary Hemi-Artery SG Used in heart surgery

Reason for Recall

Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.

Distribution Pattern

US distribution in CA.

Code Information

Serial No. 10119759, Model SGPH00

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  • 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)