BEUDAMED
    FDA Enforcement Class II 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 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2870-2016
    Event ID
    74952
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Global Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 28, 2016
    Initiation Date
    August 9, 2016
    Classification Date
    September 22, 2016
    Termination Date
    January 23, 2017
    Address
    11350 Old Roswell Rd, Suite 700, Alpharetta, GA, 30009-2291, United States

    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.

    Code Info

    Model Number: MED 5223, Lot Number: 201505 l0

    Distribution

    FL

    Quantity

    282 cartons (1000 units per carton)