BEUDAMED
    FDA Enforcement Class II Terminated

    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

    Recall: Z-2617-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2617-2021
    Event ID
    88596
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    October 17, 2017
    Classification Date
    September 30, 2021
    Termination Date
    June 14, 2022
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

    Reason

    Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

    Code Info

    Lot Number: 5210162 (UDI): H96560M7019951

    Distribution

    Canada

    Quantity

    4 boxes (5/each)= 20 eaches