BEUDAMED
    FDA Enforcement Class II Terminated

    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    Recall: Z-1240-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1240-2014
    Event ID
    67588
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Convatec Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    February 7, 2014
    Classification Date
    March 19, 2014
    Termination Date
    December 18, 2014
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558-2600, United States

    Description

    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    Reason

    The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

    Code Info

    540204R001

    Distribution

    Worldwide Distribution and in the state of TX

    Quantity

    54,590 catheters