Belmont Instrument LLC

6 FDA enforcement actions

6 Total Recalls

0 Class I

6 Class II

0 Class III

Firm Details

Product Types: device
States: MA

All Recalls

Class II: Risk 05/13/2025 device

An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
Class II: Risk 03/31/2025 device

Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Class II: Risk 03/31/2025 device

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Class II: Risk 03/31/2025 device

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Class II: Risk 03/31/2025 device

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Class II: Risk 01/02/2025 device

Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.