BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-1678-2025 · Initiated March 31, 2025

    Recall

    Recall Number
    Z-1678-2025
    Event Number
    96625
    Firm
    Belmont Instrument LLC
    FEI Number
    1219702
    Product Code
    LGZ
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    March 31, 2025
    Posted
    April 25, 2025
    Address
    780 Boston Rd, Billerica, MA, 01821-5925

    Description

    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.

    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.

    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.

    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.

    Quantity

    603 cases (2,412 sets)