BEUDAMED
    FDA Recall Terminated

    Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.

    Recall: Z-0830-06 · Initiated January 25, 2006

    Recall

    Recall Number
    Z-0830-06
    Event Number
    34535
    Firm
    Medtronic Gastroenterology Urology
    FEI Number
    1000135098
    Product Code
    FFT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 25, 2006
    Posted
    May 3, 2006
    Terminated
    December 21, 2006
    Address
    4000 Lexington Ave N, Shoreview, MN, 55126-2917

    Description

    Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.

    Reason

    Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.

    Action

    An Urgent Recall letter was issued to all affected customers 1/25/2006. This letter described the issue and listed what actions customers were to take to return affected product.

    Distribution

    within US only: MI, PA, TX

    Quantity

    25 individual catheters