BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1714-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1714-2020
    Event ID
    85215
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 22, 2020
    Initiation Date
    March 12, 2020
    Classification Date
    April 15, 2020
    Termination Date
    August 31, 2022
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681, United States

    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.

    Code Info

    Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.

    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.