BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)

    Recall: Z-0174-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0174-2023
    Event ID
    90972
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson Infusion Therapy Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2022
    Initiation Date
    October 12, 2022
    Classification Date
    November 3, 2022
    Address
    9450 S State St, N/A, Sandy, UT, 84070-3213, United States

    Description

    BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)

    Reason

    During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).

    Code Info

    Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865

    Distribution

    U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. O.U.S.: N/A

    Quantity

    56,080 units