BEUDAMED
    FDA Enforcement Class I Terminated

    Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.

    Recall: Z-1114-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1114-2021
    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 Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.

    Reason

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

    Code Info

    Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857

    Distribution

    US Nationwide Distribution

    Quantity

    954 units