BEUDAMED
    FDA Enforcement Class II Ongoing

    Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.

    Recall: Z-0197-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0197-2024
    Event ID
    93116
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Quest Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 8, 2023
    Initiation Date
    July 14, 2023
    Classification Date
    October 28, 2023
    Address
    1 Allentown Pkwy, N/A, Allen, TX, 75002-4206, United States

    Description

    Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.

    Reason

    For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

    Code Info

    Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007

    Distribution

    US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada

    Quantity

    17,700 units