BEUDAMED
    FDA Enforcement Class II Ongoing

    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759

    Recall: Z-1341-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1341-2024
    Event ID
    94035
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Angiodynamics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2024
    Initiation Date
    January 30, 2024
    Classification Date
    March 21, 2024
    Address
    603 Queensbury Ave, Queensbury, NY, 12804-7619, United States

    Description

    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759

    Reason

    Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

    Code Info

    UDI: 15051684023023 UPN: H965457591 Lot Number: 5789493 5789494 5789495 5789496 5789497 5791596 5791597 5791598 5793392 5793393 5794602 5794603 5794604 5794605 5794606 5795874 5795875 5797457 5797458 5797466 5797467 5798837 5798843 5798844

    Distribution

    Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.

    Quantity

    5840 units