BEUDAMED
    FDA Enforcement Class II Ongoing

    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

    Recall: Z-1156-2023 · Reported March 1, 2023

    Enforcement

    Recall Number
    Z-1156-2023
    Event ID
    91533
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Access Vascular, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2023
    Initiation Date
    December 22, 2022
    Classification Date
    February 22, 2023
    Address
    749 Middlesex Tpke, N/A, Billerica, MA, 01821-3906, United States

    Description

    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

    Reason

    Label with the incorrect component listed on the inner kit Tyvek header bag

    Code Info

    UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076

    Distribution

    US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.

    Quantity

    445 units