Recall Z-1678-2025 ยท LGZ Warmer, Thermal, Infusion Fluid
Belmont Instrument LLC
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.
| Date | Apr 25, 2025 (initiated Mar 31, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/m Belmont Medical Technologies, Dec 23, 2024 |