BEUDAMED
    FDA Enforcement Class I Ongoing

    ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

    Recall: Z-0067-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0067-2022
    Event ID
    88640
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    National Distribution & Contracting Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    August 24, 2021
    Classification Date
    October 13, 2021
    Address
    407 New Sanford Rd, N/A, La Vergne, TN, 37086-4184, United States

    Description

    ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

    Reason

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

    Code Info

    All lots for the following distributed product codes: Product Code: ECO 85CB - ECO 85CB Lotion Ultrasound 8.5 oz 24/cs Product Code: ECO 40JBC - ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs Product Code: ECO 40JMC - ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs Product Code: NDC P301008 - NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs Product Code: NDC P301105 - NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs Product Code: NDC P301115 - NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs Product Code ECO 30GS - ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl Product Code: ECO 30GB - ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of RI, AL, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, IL, IN, KS, KY, MA, MD, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Canada and Nova Scotia.

    Quantity

    25103 units