BEUDAMED
    FDA Enforcement Class I Ongoing

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    Recall: Z-2480-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2480-2021
    Event ID
    88584
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AMTEC SALES Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 29, 2021
    Initiation Date
    August 12, 2021
    Classification Date
    September 22, 2021
    Address
    1594 Nw 159th St, Miami, FL, 33169-5635, United States

    Description

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    Reason

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

    Code Info

    1) Ecogel 100 Imaging Gel, 250 mL bottle, Print Media Item Number 3541420 (12 each/pack; 72 each/case) 2) Ecogel 100 Imaging Gel, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 3874672 (1 each/pack; 4 each/case) 3) Ecogel 200 Multipurpose Gel BLUE, 250mL bottle, Print Media Item Number 3113545 (12 each/pack, 72 each/case) 4) Ecogel 200 Multipurpose Gel BLUE, Set: 5L jug with 250mL dispenser, Print Media Item Number 1000033 (1 each/pack, 4 each/case) 5) Ecogel 200 Multipurpose Gel CLEAR, 250mL bottle, Print Media Item Number 3158655 (12 each/pack, 72 each/case) 6) Ecogel 200 Multipurpose Gel CLEAR, Set: 5L jug with 250mL dispenser, Print Media Item Number 7565432 (1 each/pack, 4 each/case) 7) Ecolotion Transmission Lotion, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 6115004 (1 each/pack, 4 each/case)

    Distribution

    Worldwide Distribution to US (nationwide) states of - FL, TX, OH, MD, PA, WA, CO, PR, VA, KY, OK, and CA; and OUS (international) to countries of - Honduras, Dominican Republic, El Salvador, Guatemala, Panama, and Costa Rica.

    Quantity

    34,586 each