Ultrasound gel products recalled for potential bacterial contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Although no illnesses or injuries have been reported in the source text, the rubric requires that FDA Class I recalls never score below 4 (Severe).
Plain-English summary
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled because they may contain bacterial contamination. The recalled product is the ECO 50TS Gel Tens Ultrasound, distributed in 1-inch by 5-liter containers.
The affected product (3 units) was distributed nationwide across the United States and internationally to Canada. All lots of product code ECO 50TS are included in this recall.
If you have this product, stop using it and contact National Distribution & Contracting Inc for instructions on how to return or dispose of the recalled product.
The recalled product
- Product
- ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
- Manufacturer
- National Distribution & Contracting Inc
- Category
- Medical Device — Ultrasound Gel
- Hazard
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 2 recalled by National Distribution & Contracting Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · National Distribution & Contracting Inc
See all →- SevereFDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
FDA (Devices) · 2021-10-20
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