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.
FDA Recall Z-1678-2025 · Posted 2025-04-25
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Recalling FirmBelmont Instrument LLC
Recall StatusOpen, Classified
Product CodeLGZ
Date Initiated2025-03-31
Product Quantity603 cases (2,412 sets)
Reason for Recall
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.
Firm Action
Belmont Medical notified consignees on about 03/31/2025 via "URGENT MEDICAL DEVICE CORECTION" FedEx or emailed letter. Consignees were instructed to locate affected product and to return the customer Response Form indicating if any affected units were on hand. Consignees were also instructed to follow instructions provided in the letter to inspect affected lots and if any units are identified as having cracks or leaks during priming, they should be discarded. Lot number of the set should be noted and reported to Belmont Medical Technologies. Belmont has indicated that they will replace any product found defective or at the request of the user any affected product that has not been used.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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