BEUDAMED
    FDA Recall 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 · Initiated May 12, 2015

    Recall

    Recall Number
    Z-1801-2015
    Event Number
    71247
    Firm
    Vidacare Corporation
    FEI Number
    3007134520
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 12, 2015
    Posted
    June 15, 2015
    Terminated
    April 11, 2016
    Address
    4350 Lockhill Selma Rd, Suite 150, Shavano Park, TX, 78249-2162

    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

    Action

    Teleflex sent an Urgent Medical Recall Notification dated May 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter directed the customers to quarantine the affected product and return it to the manufacturer. If you have any further questions please call 1-866-246-6990.

    Distribution

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

    Quantity

    2,104 boxes