Recall Z-0067-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
National Distribution & Contracting Inc
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispe
| 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 | 25103 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
| K955246 | ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., Feb 21, 1996 |