BEUDAMED
    FDA Enforcement Class II Ongoing

    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

    Recall: Z-0720-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0720-2023
    Event ID
    91138
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cordis US Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    November 7, 2022
    Classification Date
    December 15, 2022
    Address
    14201 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

    Reason

    There is a potential for separation at the male connector.

    Code Info

    UDI-DI: (01)2070532064702; Catalog Number (Lot Number): 502-100D (18068258, 18069744, 18101041, 18111609); 502-101D (18062881, 18081307, 18064731, 18086388, 18066535, 18097369, 18070824, 18102623, 18077497); 502-102D (18060997, 18078225, 18099118, 18062882, 18079156, 18104313, 18064732, 18083133, 18106093, 18072508, 18084892, 18108019, 18074058, 18088193, 18109512, 18076420, 18090247)

    Distribution

    Nationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.

    Quantity

    16,950 units (2,915 US and 14,000 OUS)