Nephros shares plummet after the medical device company recalls its SafeSpout and SafeShower hospital water filters on reports of bacterial contamination and an FDA warning on alleged false advertising for another of its filters.
Nephros (OTC:NEPH) shares plummeted nearly 68% today after it issued a recall of 3 of its in-line ultrafilters after receiving reports of bacterial contamination that may have led to a patient's death.
Nephros said it received reports about its SafeSpout and SafeShower point-of-use filters from 1 customer of "high bacterial counts" likely due to "the breakage of fiber in 4 filters" that may have led to the death and to another instance of infection, according to a regulatory filing
The company logged another 29 complaints of high bacterial counts that were not associated with any adverse events, according to the filing.
River Edge, N.J.-based Nephros said the recall is also due to an FDA warning that its dual-stage-use filters were advertised using "promotional materials for these non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device," according to a regulatory filing.
The news sent NEPH shares down 67.5% to 38¢ apiece as of about 11 a.m. today.
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