BEUDAMED
    FDA Recall 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 · Initiated April 15, 2020

    Recall

    Recall Number
    Z-1970-2020
    Event Number
    85585
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    MJC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 15, 2020
    Terminated
    May 20, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    Customer/Distributer letters were mailed on April 27, 2020 via FedEx and email. BD will request distributors to conduct a sub-recall on BDs behalf. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers and distributors discard affected unit(s). Any unit(s) that are returned to BD will be quarantined upon arrival and discarded per procedure.

    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