ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Summary
The FDA issued a Class I for ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl by National Distribution & Contracting Inc. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..
Details
Source
Device Recall
External ID
Z-0068-2022
Action Date
2021-10-20
Status
Ongoing
Category
device
Product Description
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Lot/Code Info: All lots for the following distributed product code: Product Code: ECO 50TS - ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser
Quantity Affected: 3 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-24
Company
La Vergne, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
National Distribution & Contracting Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (National Distribution & Contracting Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does National Distribution & Contracting Inc have FDA actions?
National Distribution & Contracting Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0068-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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