FDA recall Z-0439-2024

CardioQuip, LLC · Class II · device

Product

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

Reason for recall

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

Distribution

US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA

Key facts

Status
Ongoing
Initiation date
2023-10-19
Report date
2023-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
College Station, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0439-2024