FDA recall Z-0565-2024

CardioQuip, LLC · Class II · device

Product

CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A

Reason for recall

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

Distribution

US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None

Key facts

Status
Ongoing
Initiation date
2023-10-24
Report date
2023-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
College Station, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2024