BEUDAMED
    FDA Enforcement Class II Ongoing

    Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

    Recall: Z-1700-2023 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1700-2023
    Event ID
    92082
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 14, 2023
    Initiation Date
    April 20, 2023
    Classification Date
    June 8, 2023
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497, United States

    Description

    Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

    Reason

    Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

    Code Info

    a) REF 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445

    Distribution

    Worldwide

    Quantity

    5760 devices