BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.

    Recall: Z-2116-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2116-2020
    Event ID
    85411
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.A. Greiner & Sohne Gesellschaftmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    April 3, 2020
    Classification Date
    May 26, 2020
    Termination Date
    July 25, 2021
    Address
    Greiner St. #70, N/A, Kremsmunster, N/A, N/A, Austria

    Description

    VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.

    Reason

    While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.

    Code Info

    Item no. 450225. UDI no. 39120017577547 and 29120017577540.

    Distribution

    *requested 4/15/2020

    Quantity

    90,400 pieces.