medical Class II Updated 2018-06-27

CryoLife, Inc. recalls Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number

Recalled Product

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO


Hazard / Issue

Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

Issued by

FDA

Affected States: AR, OH
Lot/Code Info: Serial Number 10988203
View official government recall

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