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Belmont Instrument LLC FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Allon 2001. Part Number: 200-00263Class IIMay 13, 2025An investigation into a report of the patient wrap (ThermoWr |
| Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the HyperthClass IIMar 31, 2025Potential crack in the female connector located on the Heat |
| Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with thClass IIMar 31, 2025Potential crack in the female connector located on the Heat |
| 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume ReseClass IIMar 31, 2025Potential crack in the female connector located on the Heat |
| Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used withClass IIMar 31, 2025Potential crack in the female connector located on the Heat |
| Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operatioClass IIJan 2, 2025Disposable set may leak during priming from a female quick c |