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Recall Observatory FDA recall evidence

Device product

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

Z-0068-2022

August 24, 2021

Class I

Product summary

Firm
National Distribution & Contracting Inc
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

    reason.microbial_contamination · v1.0.0

    bacterial contamination