BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    Recall: Z-2485-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2485-2021
    Event ID
    88511
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 6, 2021
    Initiation Date
    August 13, 2021
    Classification Date
    September 24, 2021
    Termination Date
    August 16, 2023
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States

    Description

    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    Reason

    Blood collection tubes may experience a clotting issue.

    Code Info

    Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.

    Distribution

    Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.

    Quantity

    962,400 tubes