BEUDAMED
    FDA Enforcement Class II Terminated

    RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

    Recall: Z-1732-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1732-2014
    Event ID
    68350
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    May 21, 2014
    Classification Date
    June 9, 2014
    Termination Date
    November 23, 2015
    Address
    2917 Weck Dr., N/A, Research Triangle Park, NC, 27709, United States

    Description

    RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

    Reason

    Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

    Code Info

    Product Code: ECK103, Lot number: 02A1402484

    Distribution

    US Distribution including the states of CA, FL, OH and OK.

    Quantity

    1000 eaches