Recall Z-1676-2025 ยท LGZ Warmer, Thermal, Infusion Fluid
Belmont Instrument LLC
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separa
| Date | Apr 25, 2025 (initiated Mar 31, 2025) |
| Status | Open, Classified |
| Reason | Potential crack in the female connector located on the Heat Exchanger in the 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 | 136 sets |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152208 | The Belmont Hyperthermia Pump Belmont Instrument Corporation, Sep 2, 2015 |