BEUDAMED
    FDA Enforcement Class II Terminated

    T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation

    Recall: Z-1801-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1801-2015
    Event ID
    71247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vidacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    May 12, 2015
    Classification Date
    June 15, 2015
    Termination Date
    April 11, 2016
    Address
    4350 Lockhill Selma Rd, Suite 150, Shavano Park, TX, 78249-2162, United States

    Description

    T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation

    Reason

    Potential breach in sterility

    Code Info

    3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, 4040724

    Distribution

    US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.

    Quantity

    2,104 boxes