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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device."
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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