BEUDAMED
    FDA Recall Open, Classified

    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)

    Recall: Z-2582-2021 · Initiated August 27, 2021

    Recall

    Recall Number
    Z-2582-2021
    Event Number
    88613
    Firm
    North Coast Medical Inc
    FEI Number
    1000124207
    Product Code
    ITX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 27, 2021
    Address
    780 Jarvis Dr, Ste 100, Morgan Hill, CA, 95037-2885

    Description

    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)

    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

    Action

    On 08/17/2021, an online posting went live informing customers to discontinue use of affected products. On 08/27/21, recall notices were mailed to customers. Customers were asked to do the following: 1) Immediately examine your inventory and discontinue use, quarantine, and stop distribution of all affected gels and lotions manufactured by Eco-Med Pharmaceutical. 2) If affected product has been further distributed, notify customers, and forward the recall notification down to the user level. If you have any questions concerning this communication, please don t hesitate to contact [email protected]. 3) Complete and return the Recall Acknowledgment and Disposal Form via email/mail. A contact telephone number was also provided: 800-821-9319, Monday thru Friday 6:00AM-4:00PM (PST)

    Distribution

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

    Quantity

    576