BEUDAMED
    FDA Recall 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 · Initiated April 12, 2013

    Recall

    Recall Number
    Z-1303-2013
    Event Number
    64908
    Firm
    Covidien LLC
    FEI Number
    1282497
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 12, 2013
    Posted
    May 11, 2013
    Terminated
    June 2, 2015
    Address
    15 Hampshire Street, Mansfield, MA, 02048-1113

    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.

    Action

    US Customers were notified of the recall by letter sent by Federal Express on April 12, 2013. The letter requests that they immediately stop using any affected product, quarantine it, and return it to Covidien. Consignees were asked to return a verification form and return it to Covidien via fax.

    Distribution

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

    Quantity

    17740 kits