ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Recall
- Recall Number
- Z-0068-2022
- Event Number
- 88640
- Firm
- National Distribution & Contracting Inc
- FEI Number
- 2124637
- Product Code
- GYB
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 24, 2021
- Address
- 407 New Sanford Rd, La Vergne, TN, 37086-4184
Description
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
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 [email protected] 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 [email protected] To contact National Distribution & Contracting, Inc. directly with questions email [email protected] 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
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.
3 units