FDA recall Z-0068-2022

National Distribution & Contracting Inc · Class I · device

Product

ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

Reason for recall

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

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.

Key facts

Status
Ongoing
Initiation date
2021-08-24
Report date
2021-10-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
La Vergne, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2022