FDA recall Z-0153-2023

Belmont Instrument Corporation · Class II · device

Product

CritiCool, thermoregulation device

Reason for recall

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.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status: Ongoing
Initiation date: 2021-07-20
Report date: 2022-11-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2023