Class 2 Device Recall HydroDot brand Wave Prep

• Date Initiated by Firm: October 29, 2019
• Date Posted: December 18, 2019
• Recall Status: Terminated on September 07, 2021
• Recall Number: Z-0704-2020
• Recall Event ID: 84305
• 510(K)Number: K970694
• Product Classification: Degreaser, skin, surgical - Product Code KOY
• Product: 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.
• Code Information: Product 1710-03: Lot # 29688 Expanded: Lot # 31160
• Recalling Firm/ Manufacturer: Bio-Signal Group Corp.; 3 Post Office Sq Ste K; Acton MA 01720-3956
• For Additional Information Contact: SAME; 978-429-8756
• Manufacturer Reason for Recall: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
• FDA Determined Cause: Process control
• 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: recall@biosignalgroup.com 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 recall@biosignalgroup.com 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: recall@biosignalgroup.com, 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
• Quantity in Commerce: 1,500 tubes Expanded: 203 boxes (3/box)
• Distribution: US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KOY