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FDAMarch 31, 2025device

3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

belmont instrumentbelmont

UPCs

00896128002534

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment... — Recall Details · AllClear