BEUDAMED
    FDA Enforcement Class II Terminated

    PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

    Recall: Z-0407-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0407-2018
    Event ID
    78883
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Inovo, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    October 9, 2017
    Classification Date
    January 24, 2018
    Termination Date
    September 15, 2023
    Address
    401 Leonard Blvd N, N/A, Lehigh Acres, FL, 33971-6302, United States

    Description

    PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

    Reason

    Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).

    Code Info

    UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers

    Distribution

    worldwide

    Quantity

    13,140 units