BEUDAMED
    FDA Enforcement Class III Terminated

    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

    Recall: Z-1303-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1303-2013
    Event ID
    64908
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    April 12, 2013
    Classification Date
    May 11, 2013
    Termination Date
    June 2, 2015
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113, United States

    Description

    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

    Reason

    On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.

    Code Info

    Product 80530: 032887164, 203184264,110983764, 208286764, 116480564, 221590564, 120987864, 236385564,127085464; Product 8508: 207383964, 23489464

    Distribution

    Worldwide distribution: USA (nationwide) and in the country of: Panama.

    Quantity

    17740 kits