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

Recall date

October 24, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0565-2024

FDA classification

Class II

Brand / firm

CardioQuip, LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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