BEUDAMED
    FDA Enforcement Class I Ongoing

    MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).

    Recall: Z-1730-2025 · Reported May 21, 2025

    Enforcement

    Recall Number
    Z-1730-2025
    Event ID
    96646
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nipro Renal Soultions USA, Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2025
    Initiation Date
    April 11, 2025
    Classification Date
    May 14, 2025
    Address
    509 Fishing Creek Rd, Lewisberry, PA, 17339-9517, United States

    Description

    MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).

    Reason

    Potential for the presence of visible foreign matter.

    Code Info

    a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All lot numbers. b. Model Number: BC+100 36.83X. Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817. Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama.

    Quantity

    816,840 units (BC+201), 39,228 units (BC+100)