BEUDAMED
    FDA Enforcement Class I Terminated

    Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.

    Recall: Z-1113-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1113-2021
    Event ID
    87084
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Combat Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 24, 2021
    Initiation Date
    December 23, 2020
    Classification Date
    February 18, 2021
    Termination Date
    July 9, 2024
    Address
    5555 Harrisburg Ind Pk Dr, N/A, Harrisburg, NC, 28075-7407, United States

    Description

    Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.

    Reason

    There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

    Code Info

    Lot numbers: MFG2980, MFG3051, MFG3059, MFG3069, MFG3070, MFG3096, MFG3101, MFG3107, MFG3127, MFG3138, MFG3164, MFG3174, MFG3193, MFG3203, MFG3217, MFG3228, MFG3234, MFG3239, MFG3258, MFG3264, MFG3277, MFG3302, MFG3112, MFG3331, MFG3373, MFG3354, MFG3382, MFG3387, MFG3394, MFG3399, MFG3427, MFG3431, MFG3463, MFG3482, MFG3498, MFG3519, MFG3521, MFG3555, MFG3583, MFG3572, MFG3622, MFG3653, MFG3676, MFG3734, MFG3742, MFG3755, MFG3758, MFG3762, MFG3801, MFG3802, MFG3839, MFG3861, MFG3870, MFG3876

    Distribution

    US Nationwide Distribution

    Quantity

    27090 units