BEUDAMED
    FDA Enforcement Class II Ongoing

    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

    Recall: Z-1129-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1129-2023
    Event ID
    91426
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Access Vascular, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2023
    Initiation Date
    December 16, 2022
    Classification Date
    February 10, 2023
    Address
    749 Middlesex Tpke, N/A, Billerica, MA, 01821-3906, United States

    Description

    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

    Reason

    Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

    Code Info

    UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226

    Distribution

    US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

    Quantity

    1,789 HydroMID devices