BEUDAMED
    FDA Enforcement Class II Terminated

    BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

    Recall: Z-1359-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1359-2016
    Event ID
    72922
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    December 18, 2015
    Classification Date
    April 8, 2016
    Termination Date
    June 29, 2016
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

    Reason

    Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

    Code Info

    CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

    Distribution

    Distributed US (nationwide) and the countries of Canada and Australia.

    Quantity

    1,428,000 units (total)