BEUDAMED
    FDA Recall Terminated

    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - 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 electrode. The Wave Prep cups are a component in the Subject Kit.

    Recall: Z-0675-2020 · Initiated November 7, 2019

    Recall

    Recall Number
    Z-0675-2020
    Event Number
    84324
    Firm
    Neuronetrix Solutions, LLC dba Cognision
    FEI Number
    3011184129
    Product Code
    KOY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 7, 2019
    Terminated
    October 26, 2020
    Address
    1044 E Chestnut St, Louisville, KY, 40204-6033

    Description

    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - 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 electrode. The Wave Prep cups are a component in the Subject Kit.

    Reason

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

    Action

    Cognison notified customers and/or end users via email and/or telephone. Customer who received more than 20 units of the affected Wave Prep cups were initially notified by phone on 11/7/2019. All customers were then sent an email with an attached recall letter also on 11/7/2019. Letter states reason for recall, health risk and action to take: Please review your inventory of the Subject Kit (Clinical Grade), Model 3000, Order No. D5000 and immediately discontinue use and quarantine any of the affected product with lot numbers shown above. Customers have been instructed to dispose of the affected product as medical waste. Customer to return notice via email to [email protected]. If you dont have any affected product, you may call Cognision Customer Service at 800-561-9040 and inform the Customer Service Representative that you have no affected product. Alternatively, you mail email [email protected] and provide this information

    Distribution

    US Nationwide distribution.

    Quantity

    3,108 units