FDA recall Z-2271-2018

Product

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

Reason for recall

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

Distribution

AR, OH

Key facts

Status

Terminated

Initiation date

2018-05-14

Report date

2018-06-27

Termination date

2019-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2271-2018