BEUDAMED
    FDA Enforcement Class I Terminated

    Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.

    Recall: Z-1110-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1110-2021
    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

    Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the 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: MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671

    Distribution

    US Nationwide Distribution

    Quantity

    531 units