BEUDAMED
    FDA Recall Terminated

    HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - 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-0704-2020 · Initiated October 29, 2019

    Recall

    Recall Number
    Z-0704-2020
    Event Number
    84305
    Firm
    Bio-Signal Group Corp.
    FEI Number
    3006315274
    Product Code
    KOY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 29, 2019
    Posted
    December 18, 2019
    Terminated
    September 7, 2021
    Address
    3 Post Office Sq, Ste K, Acton, MA, 01720-3956

    Description

    HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - 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)

    Action

    Bio-Signal issued Email notification on 10/29/2019 advising reason for recall, health risk and action to take: Distributors - Actions to be taken: 1)Please immediately cease distribution of the affected product. 2)Please examine your inventory for the affected product, quarantine the affected product and complete the attached response form to Bio-Signal Group by email to: [email protected] 3)If you have further distributed this product to: "Domestic customers: please notify your customers at once and request that they contact Bio-Signal Group directly at 978-429-8756 (Monday Friday, 8:30 AM to 5:00 PM EDT) or by email at [email protected] for further instructions. "International customers: please notify your customers at once and request that they quarantine and dispose the affected product and respond with the attached response to yourself. You can elect to send them replacements or credit. Customers - Actions to be taken: 1)Please immediately cease use of the affected product lot numbers in the above table. 2) If you still have any of the affected lots in your inventory, we are requesting that you immediately quarantine those products and return them to Bio-Signal Group. If you will not return any product please inform Bio-Signal Group that there are none to return. 3) To initiate return of product, please fill out the attached response form and send to Bio-Signal Group by email to: [email protected], and we will provide you with a return authorization code and return shipping labels. Our customer representative number is 978-429-8756. EXPANDED RECALL: Biosignal initated telephone calls, emails on 12/31/9 with consignees on to quarantine inventory of the following: 1710-03 4oz tubes with 3 tubes in each box, lot 31160 and 1700-24 Single use cups in boxes of 24 cups, lot numbers: 31320, 31365. A formal Recall Amended Urgent Medical Device Notification issued to customers on 2/xx/20 stating background of recall and r

    Distribution

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

    Quantity

    1,500 tubes Expanded: 203 boxes (3/box)