BEUDAMED
    FDA Recall Terminated

    Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)

    Recall: Z-2168-2008 · Initiated April 25, 2008

    Recall

    Recall Number
    Z-2168-2008
    Event Number
    48612
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 25, 2008
    Posted
    September 4, 2008
    Terminated
    May 15, 2012
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)

    Reason

    The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.

    Action

    Affected customers contacted by letter "Medtronic Urgent: Medical device Recall April 2008" that indicates that some Medela Vario 18 Vacuum Pumps were provided with an incorrect Suction Jar Lid that did not have the correct Conical Connection for the Vacuum Tube and the method to obtain a replacement part if needed. The letter requires customers to locate the Vacuum Pump serial number and compare it against the Serial Number on the Reply Form provided. Next customers are to review the Suction Jar Lid and check the part number. "Reply form and Instruction for Receiving Replacement Lid " included. Contact Medtronic 1-800-707-0933 for assistance.

    Distribution

    USA including states of OH, DE, CT, KY, AR, NY, MA, CA, GA, NC, MI, WI, TX, PA, MD, and country of CANADA.

    Quantity

    1500 pumps (20 affected)