Recall Z-0068-2022 ยท GYB Media, Electroconductive
National Distribution & Contracting Inc
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
| Date | Aug 24, 2021 |
| Status | Open, Classified |
| Reason | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962681 | ECOGEL 300 TENS GEL Eco-Med Pharmaceuticals, Inc., Oct 4, 1996 |