FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
Ultrasound gels and lotions from National Distribution & Contracting Inc are being recalled due to potential bacterial contamination. About 25,103 units distributed nationwide and in Canada are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for bacterial contamination in medical devices. No illnesses or injuries have been reported in the source material.
Plain-English summary
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. and distributed by National Distribution & Contracting Inc are subject to an FDA Class I recall. The recalled products include ECO 85CB Lotion Ultrasound, ECO 40JBC Gel, ECO 40JMC Gel, ProAdvantage Gel and Lotion variants, and Ecogel 100 Ultrasound products, totaling 25,103 units.
The recall was initiated due to potential bacterial contamination in these ultrasound transmission gels and lotions.
The affected products were distributed nationwide throughout the United States and internationally to Canada and Nova Scotia. All lots of the specified product codes are included in the recall.
The recalled product
- Product
- ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter
- Manufacturer
- National Distribution & Contracting Inc
- Hazard
- Affected units
- 25,103
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
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FDA (Devices) · 2021-10-20
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