BEUDAMED
    FDA Recall Terminated

    Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.

    Recall: Z-1431-2021 · Initiated January 11, 2021

    Recall

    Recall Number
    Z-1431-2021
    Event Number
    87163
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 11, 2021
    Terminated
    February 2, 2023
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.

    Reason

    The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

    Action

    All customers will be contacted via letters sent via Fed Ex. 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 discard affected components.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.

    Quantity

    9,800 Units