BEUDAMED
    FDA Recall Terminated

    MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.

    Recall: Z-2870-2016 · Initiated August 9, 2016

    Recall

    Recall Number
    Z-2870-2016
    Event Number
    74952
    Firm
    Global Healthcare Inc
    FEI Number
    1000140469
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 9, 2016
    Posted
    September 22, 2016
    Terminated
    January 23, 2017
    Address
    11350 Old Roswell Rd, Suite 700, Alpharetta, GA, 30009-2291

    Description

    MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.

    Reason

    The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.

    Action

    The distributors were first notified on August 9, 2016 via phone to place product on hold. They were notified of the recall on August 10, 20l6 by email.

    Distribution

    FL

    Quantity

    282 cartons (1000 units per carton)