Belmont Instrument Corporation recalls CritiCool, thermoregulation device

Recall date

July 20, 2021

Source

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

Recall number

Z-0153-2023

FDA classification

Class II

Brand / firm

Belmont Instrument Corporation

Sold / distributed

Domestic distribution nationwide. Foreign distribution worldwide.

Why it was recalled

Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.

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

What was recalled

CritiCool, thermoregulation device