BEUDAMED
    FDA Enforcement Class II Terminated

    Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

    Recall: Z-2507-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2507-2021
    Event ID
    88563
    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
    September 29, 2021
    Initiation Date
    August 20, 2021
    Classification Date
    September 22, 2021
    Termination Date
    October 4, 2023
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681, United States

    Description

    Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

    Reason

    Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

    Code Info

    Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.

    Quantity

    956,400