BEUDAMED
    FDA Enforcement Class II Ongoing

    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    Recall: Z-1605-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1605-2023
    Event ID
    92124
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Access Vascular, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    March 3, 2023
    Classification Date
    May 18, 2023
    Address
    749 Middlesex Tpke, N/A, Billerica, MA, 01821-3906, United States

    Description

    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    Reason

    The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

    Code Info

    UDI-DI: 00862559000487; Lot Number: 11423949

    Distribution

    US distribution to States of: FL, TN, TX.

    Quantity

    240 units