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 Model Number: 80004004

    Recall: Z-1155-2023 · Reported March 1, 2023

    Enforcement

    Recall Number
    Z-1155-2023
    Event ID
    91529
    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 Model Number: 80004004

    Reason

    Product Mislabeled on the outer bag and inner kit Tyvek header bag

    Code Info

    UDI: (01)00850030354020 Lot Number: 11434018

    Distribution

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

    Quantity

    155 units