BEUDAMED
    FDA Enforcement Class II Terminated

    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

    Recall: Z-0010-2013 · Reported October 10, 2012

    Enforcement

    Recall Number
    Z-0010-2013
    Event ID
    63136
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc., Urological Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2012
    Initiation Date
    September 7, 2012
    Classification Date
    October 4, 2012
    Termination Date
    March 21, 2013
    Address
    8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States

    Description

    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

    Reason

    The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

    Code Info

    Catalog # 165808, Lot # NGWA1111

    Distribution

    Nationwide distribution: USA and Puerto Rico

    Quantity

    4,032 units