Device product
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Z-0068-2022
Product summary
- Event
- Event 88640
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0068-2022
Official wording
Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
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
Distribution pattern: 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.
Derived failure modes
-
Microbial contamination
bacterial contamination