BEUDAMED
    FDA Recall Terminated

    Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA

    Recall: Z-0392-06 · Initiated December 9, 2005

    Recall

    Recall Number
    Z-0392-06
    Event Number
    34246
    Firm
    Medtronic Gastroenterology Urology
    FEI Number
    1000135098
    Product Code
    FFT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 9, 2005
    Posted
    January 13, 2006
    Terminated
    December 21, 2006
    Address
    4000 Lexington Ave N, Shoreview, MN, 55126-2917

    Description

    Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA

    Reason

    Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.

    Action

    Letters will be sent to distributors, end-users and Medtronic Field Personnel. The end-user will be asked to return via fax a confirmation/customer receipt. Letters identify the affected catalog number and lot numbers. Customers are asked to return affected product and will receive replacement product.

    Distribution

    CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal

    Quantity

    140 catheters