Class 1 Device Recall ECO

• Date Initiated by Firm: August 24, 2021
• Create Date: October 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0068-2022
• Recall Event ID: 88640
• 510(K)Number: K962681
• Product Classification: Media, electroconductive - Product Code GYB
• Product: ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
• Code Information: All lots for the following distributed product code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser
• Recalling Firm/ Manufacturer: National Distribution & Contracting Inc; 407 New Sanford Rd; La Vergne TN 37086-4184
• For Additional Information Contact: 615-366-3230
• Manufacturer Reason for Recall: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
• FDA Determined Cause: Process control
• Action: Written recall notification notice titled, "URGENT MEDICAL DEVICE RECALL" was sent out to consignees via 2nd day air . The letter instructs the consignee to immediately stop using and discard products listed in the letter due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The letter continues to state, "1. Immediately destroy the all products manufactured by Eco-Med(we have included a certificate of destruction form with this letter): there are NDC private label products affected items P301008, P301105, and P301105 2. Forward this notice to any accounts to whom you have further distributed the product. 3. Please complete the Request for Credit form pictures of product to be destroyed and the Certificate of Destruction form and return via email to compliance@ndc-inc.com for credit. Credit will only be issued for on hand product that a certificate of destruction for along with the credit request is received. Please respond even if you do not have any affected product on hand, since this our only way of ensuring that all customers have been adequately notified." Instructions specific to distributors are, "Distributors must contact National Distribution & Contracting, Inc. to confirm receipt of this notice and that they are proceeding with the recall via email compliance@ndc-inc.com To contact National Distribution & Contracting, Inc. directly with questions email compliance@ndc-inc.com or call 615.366.3230 and ask for the compliance department. In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. Please complete the form indicating the product and the lot numbers you have identified and actions taken in the comment section. Your Assistance is appreciated and necessary to prevent any consumer illness or harm." The letter mentions health professionals, consumers and patients can voluntarily report observed or
• Quantity in Commerce: 3 units
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of RI, AL, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, IL, IN, KS, KY, MA, MD, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and the countries of Canada and Nova Scotia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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