BEUDAMED
    FDA Recall Terminated

    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    Recall: Z-1714-2020 · Initiated March 12, 2020

    Recall

    Recall Number
    Z-1714-2020
    Event Number
    85215
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    GIM
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 12, 2020
    Terminated
    August 31, 2022
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    Reason

    Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

    Action

    Greiner Bio-One North America Inc., notified customers on 03/12/2020 via "Urgent Product Recall" letter. The recall letter identified the affected products and requested the users to stop using the product and complete the product disposition site confirmation form. Consignees were asked to discard/destroy the affected products. If you have additional questions, please call our Technical Service at 800-815-8112.

    Distribution

    US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.

    Quantity

    1,000,800 units.