[Recalled] 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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 same case for shipm |
|---|---|
| Brand / manufacturer | Belmont Instrument LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1678-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 31 March 2025 |
| EAN / barcode | 00896128002534 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Belmont Instrument LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.