BEUDAMED
    FDA Enforcement Class II Terminated

    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

    Recall: Z-0502-2022 · Reported January 26, 2022

    Enforcement

    Recall Number
    Z-0502-2022
    Event ID
    89216
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 26, 2022
    Initiation Date
    December 9, 2021
    Classification Date
    January 18, 2022
    Termination Date
    October 10, 2023
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States

    Description

    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

    Reason

    Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

    Code Info

    Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.

    Distribution

    Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.

    Quantity

    889,200 pcs.