BEUDAMED
    FDA Enforcement Class II Terminated

    SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

    Recall: Z-1970-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1970-2020
    Event ID
    85585
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    April 15, 2020
    Classification Date
    May 13, 2020
    Termination Date
    May 20, 2021
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

    Reason

    There is potential for a white paper-type residue attached to the catheter.

    Code Info

    Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGDW1548 (Exp. 11/30/2021); NGDW0234 (Exp. 11/30/2021); NGDX4088 (Exp. 11/30/2021); NGDX4704 (Exp. 11/30/2021); NGDY0568 (Exp. 11/30/2021)

    Distribution

    US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.

    Quantity

    8392 units