BEUDAMED
    FDA Enforcement Class II Terminated

    HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.

    Recall: Z-0705-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0705-2020
    Event ID
    84305
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Signal Group Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 25, 2019
    Initiation Date
    October 29, 2019
    Classification Date
    December 18, 2019
    Termination Date
    September 7, 2021
    Address
    3 Post Office Sq Ste K, Acton, MA, 01720-3956, United States

    Description

    HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.

    Reason

    Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

    Code Info

    Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365

    Distribution

    US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.

    Quantity

    45,375 individual cups Expanded:1314 boxes (24/box)