Home / Recalls / Medical Devices
CryoLife, Inc. recalls Pulmonary Hemi-Artery SG Used in heart surgery
Recalled January 29, 2014 · FDA recall Z-0809-2014 · CryoLife
Hazard
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. · FDA Class II
Units
One
Sold at
US distribution in CA.
Description
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.
Product
Pulmonary Hemi-Artery SG Used in heart surgery
Manufacturer(s)
CryoLife, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →