FDA-Device2014-01-29Class II
Pulmonary Hemi-Artery SG Used in heart surgery
CryoLife, Inc.
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.
Sold states
US distribution in CA.
Affected count
One
Manufactured in
1655 Roberts Blvd Nw, Kennesaw, GA, United States
Products
Pulmonary Hemi-Artery SG Used in heart surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2014Don't want to check this manually?
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