Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination Risk
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.
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: The FDA classified this as a Class I recall, which requires a minimum severity score of 4. The hazard is potential bacterial contamination in a medical device used directly in clinical procedures where sterility is critical.
Plain-English summary
Ultrasound gels and lotions including EcoLotion Transmission Lotion and Myossage Lotion, manufactured by Eco-Med Pharmaceutical, Inc., are subject to an FDA Class I recall due to potential bacterial contamination. These products are used as transmission media in ultrasound procedures. On August 18, 2021, the FDA published a letter to health care providers directing immediate cessation of use.
The recall affects 53 units distributed worldwide, including the United States, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland. All lots within the expiration date are included in this recall.
Health care providers using these products should discontinue use immediately and contact their supplier for replacement products. Do not use any remaining inventory of the affected EcoLotion or Myossage Lotion.
The recalled product
- Product
- EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
- Manufacturer
- North Coast Medical Inc
- Hazard
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within the expiration date.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by North Coast Medical 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.
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