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.