Medical device recalls High risk

National Distribution & Contracting Inc recalls ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

Recall date
August 24, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0068-2022
FDA classification
Class I
Brand / firm
National Distribution & Contracting Inc
Sold / distributed
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.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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