Belmont 3.0 Liter Disposable Set Recalled for Cracked Female Connector
Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model 903-00032) due to a potential crack in the female connector on the Heat Exchanger/patient line set that can cause fluid leaks during device priming.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with a risk-of-harm hazard (fluid leakage during use). The source text does not report any illnesses or injuries, making this a theoretical risk scenario that meets the High (score 3) threshold under the rubric.
Plain-English summary
Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model Number 903-00032) distributed nationwide and internationally. The disposable set consists of 4 Large Volume Reservoirs and 4 Heat Exchanger/Patient Line sets packaged together per case.
The female quick connector on the Heat Exchanger/Patient Line set may have a crack that can lead to fluid leakage through the crack during priming of the Rapid Infuser. A total of 603 cases (2,412 sets) have been distributed across multiple U.S. states and to Czechia, Italy, and Norway.
Affected lot numbers are 20240911, 20241004, 20241011, and 20241105 (UDI-DI: 00896128002534). Patients and healthcare providers who have this product should contact Belmont Instrument LLC for instructions on return or replacement.
The recalled product
- Product
- 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
- Manufacturer
- Belmont Instrument LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: 903-00032. UDI-DI: 00896128002534. Lot Numbers: 20240911
- 20241004
- 20241011
- 20241105
Distribution
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