BEUDAMED
    FDA Recall Terminated

    Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark

    Recall: Z-0817-2007 · Initiated April 6, 2007

    Recall

    Recall Number
    Z-0817-2007
    Event Number
    37852
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    JCC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2007
    Posted
    May 22, 2007
    Terminated
    March 2, 2008
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark

    Reason

    Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.

    Action

    Customers were sent a recall notice, a customer detail sheet for this product lot, and a reply form to be used when returning the suspect bottles. Distributor was provided with a formatted templates to be used in recalling the supsect bottles from their customers and instructions on how to manage the returns and ship the bottles back to Medtronic.

    Distribution

    Nationwide.

    Quantity

    238