FDA recall Z-1545-2024

Artivion, Inc · Class II · device

Product

CryoValve SG Cryopreserved Pulmonary Human Heart Valve

Reason for recall

The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

Distribution

US Nationwide distribution in the state of Ohio.

Key facts

Status: Ongoing
Initiation date: 2024-03-06
Report date: 2024-04-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1545-2024