FDA recall Z-0073-2024

LivaNova Deutschland GmbH · Class II · device

Product

3T Heater Cooler System, REF: 16-02-85

Reason for recall

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Distribution

US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.

Key facts

Status
Ongoing
Initiation date
2023-08-03
Report date
2023-10-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2024