Drug recall
CritiCool, thermoregulation device
FDA recall event 90939 · Class II · Belmont Instrument Corporation
Key facts
| Event ID | 90939 |
|---|---|
| Recall numbers | Z-0153-2023 |
| Recalling firm | Belmont Instrument Corporation |
| Product type | Devices |
| Products | CritiCool, thermoregulation device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 20, 2021 |
| Report date | Nov 9, 2022 |
| City | Billerica |
| State | MA |
| Country | United States |
| FEI number | 1219702 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: