Device product
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Z-2271-2018
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 80199
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2271-2018
Official wording
Reason: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Code information: Serial Number 10988203
Distribution pattern: AR, OH
Derived failure modes
-
Unknown
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.