Class II — Belmont Instrument LLC
| Recalling firm | BELMONT INSTRUMENT LLC. |
|---|---|
| Registered facility | BELMONT MEDICAL TECHNOLOGIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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 shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set. |
| Quantity | 603 cases (2,412 sets) |
| Distribution | Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI. International distribution to Czechia, Italy, Norway. |
| Initiated | 2025-03-31 |
| Classified | 2025-04-25 |
| Recall number | Z-1678-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Belmont Instrument LLC (Z-1678-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96625/
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