BEUDAMED
    FDA Recall 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 · Initiated April 3, 2020

    Recall

    Recall Number
    Z-2116-2020
    Event Number
    85411
    Firm
    C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria
    FEI Number
    6368
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 3, 2020
    Terminated
    July 25, 2021

    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.

    Action

    Greiner BIO-ONE notified customers on 04/03/2020 via "Urgent Product Recall-VACUETTE Blood Transfer Unit" letter. The recall letter identified the affected product and lot numbers. The firm requested the customers to immediately isolate the defective product and complete the product disposition form.

    Distribution

    *requested 4/15/2020

    Quantity

    90,400 pieces.