Nephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims
Nephros Inc is recalling brochures for its Dual Stage Ultra Filter because the materials promoted the product as a medical device.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which the rubric defines as unlikely to cause adverse health consequences. The issue is limited to documentation and labeling errors regarding marketing claims, with no physical hazard to the product itself.
Plain-English summary
Nephros Inc is recalling promotional materials for its Dual Stage Ultra Filter (DSU) water filtration products. The recall involves brochures (Document 60-3003, Revisions 0, 1, and 2) associated with item numbers 70-0230, 70-0231, 70-0232, 70-0234, and 70-0235.
The U.S. Food and Drug Administration determined that the promotional materials contained claims that marketed the non-medical water filtration products as medical devices. This constitutes a violation of medical device marketing regulations.
The affected materials were distributed nationwide in the United States. Consumers who possess these brochures should stop using them for product information and refer to the manufacturer for accurate, non-medical usage instructions.
The recalled product
- Product
- Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
- Manufacturer
- Nephros Inc
- Hazard
- Affected units
- 3,367
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 (5)
- Item #70-0230
- 70-0231
- 70-0232
- 70-0234
- and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)
Distribution
Distributed nationwide across the United States.
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