Eco-Med Ultrasound Gels and Lotions Recalled for Bacterial Contamination
Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.
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: This is an FDA Class I recall. Although no illnesses or injuries have been reported in the source text, the FDA Class I classification indicates serious potential health consequences, requiring a minimum score of 4 per the rubric.
Plain-English summary
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. have been recalled due to potential bacterial contamination.
The FDA issued guidance on August 18, 2021, advising health care providers to discontinue use of all Eco-Med ultrasound gels and lotions.
Health care providers in possession of Eco-Med ultrasound gels or lotions should stop using these products.
The recalled product
- Product
- Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
- Manufacturer
- Aesthetics Systems Usa Inc
- Category
- Medical Device — Ultrasound Gel
- Hazard
- Affected units
- 23
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 with valid expiration dates
Distribution
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