BEUDAMED
    FDA Enforcement Class II Ongoing

    Custodiol HTK Solution, 500ml bottle. 10 per carton.

    Recall: Z-3300-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3300-2024
    Event ID
    95182
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Dr Franz Koehler Chemie Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 2, 2024
    Initiation Date
    January 9, 2024
    Classification Date
    September 26, 2024
    Address
    Werner-Von-Siemens-Str. 14-28, Bensheim, N/A, Germany

    Description

    Custodiol HTK Solution, 500ml bottle. 10 per carton.

    Reason

    Potential for particles to be present in solution.

    Code Info

    UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)

    Distribution

    US Nationwide distribution in the state of North Carolina.

    Quantity

    48 cartons (480 bottles)