BEUDAMED
    FDA Recall Terminated

    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

    Recall: Z-0194-2022 · Initiated October 14, 2021

    Recall

    Recall Number
    Z-0194-2022
    Event Number
    88863
    Firm
    Lumenis, Inc.
    FEI Number
    1720381
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 14, 2021
    Posted
    November 4, 2021
    Terminated
    August 12, 2024
    Address
    1870 S Milestone Dr, Salt Lake City, UT, 84104-6541

    Description

    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

    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 10/14/21, Recall Notification Letters and Q&A fact sheets were mailed to customers. Customers were asked to immediately stop using and discard all product subject to the recall. Customers were asked to complete and return via e-mail or fax the return response form. In addition, customers who had further distributed affected product were asked to notify their customers by sharing the recall notification letter. The following phone number was provided: 1-877-Lumenis.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of KS, PR, MO, MA, NJ, NH, CA, CO, GA, NC, NY, FL, AZ, ID, IN, TX, CT, WV, UT, LA, OH, KY, SC, WA, MN, AK, IA, MD, NM, TN, RI, PA, AR, VA, IL, MI, NE, WY, ME, WI, OK, MS, SD, NV, AL, DC, OR, VT, ND, DE, HI and the countries of AT, AU, DE, GB, HK, IT, KR, CN, FR, IE, IN, LK, JP, MO, NZ, PR, TT, TW, MN, TH, CH.

    Quantity

    11,064