BEUDAMED
    FDA Recall 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 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-1359-2016
    Event Number
    72922
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    December 18, 2015
    Terminated
    June 29, 2016
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.

    Distribution

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

    Quantity

    1,428,000 units (total)