BEUDAMED
    FDA Enforcement Class II Terminated

    Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

    Recall: Z-2079-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2079-2021
    Event ID
    88112
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    June 9, 2021
    Classification Date
    July 15, 2021
    Termination Date
    February 16, 2023
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802, United States

    Description

    Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

    Reason

    The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

    Code Info

    Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.

    Quantity

    680 units