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CryoLife, Inc. recalls Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Recalled June 27, 2018 · FDA recall Z-2271-2018 · CryoLife
Hazard
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. · FDA Class II
Units
1 unit
Sold at
AR, OH
Description
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Product
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Manufacturer(s)
CryoLife, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →