BEUDAMED
    FDA Enforcement Class I Terminated

    Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.

    Recall: Z-1112-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1112-2021
    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

    Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.

    Reason

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

    Code Info

    Lot Numbers: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640

    Distribution

    US Nationwide Distribution

    Quantity

    1021 units