BEUDAMED
    FDA Enforcement Class I Ongoing

    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

    Recall: Z-2583-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2583-2021
    Event ID
    88613
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    North Coast Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 27, 2021
    Classification Date
    September 29, 2021
    Address
    780 Jarvis Dr Ste 100, N/A, Morgan Hill, CA, 95037-2885, United States

    Description

    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

    Reason

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health

    Code Info

    All lots within the expiration date.

    Distribution

    Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland

    Quantity

    53