BEUDAMED
    FDA Enforcement Class II Terminated

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    Recall: Z-0059-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0059-2021
    Event ID
    86417
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AB ULAX
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    September 4, 2020
    Classification Date
    October 6, 2020
    Termination Date
    February 10, 2023
    Address
    Merkuriusgatan 8, N/A, Motala, N/A, N/A, Sweden

    Description

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    Reason

    Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death.

    Code Info

    SAP 109381602, Lots: 2018-09-25 2018-11-20 2018-12-10 2018-12-20 2019-01-03 2019-02-20 2019-03-20 2019-04-15 2019-05-30 2019-06-25 2019-08- 15 2019-09-05 2019- 11-05 2019-11-25 *** SAP 109381603, Lots 2019-12-20 2020-04-30 2020-05-15 2020-05-20 2020-06-15 2020-06-30

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.

    Quantity

    1,484,100 units