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SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus
including SafeSpout, SafeShower HH (Hand Held), and SafeShower FH (Fixed Head)
AUDIENCE: Risk Manager, Biomedical Engineer
ISSUE: The Nephros non-medical water filtration SafeSpout and SafeShower products may pose risks to health potentially resulting in adverse health events or death. Exposure to harmful bacteria may occur when the fiber filter or the sealing compound, holding the fiber in place, breaks apart. If the filter breaks, patients could be exposed to bacteria or viruses, which could result in infection or death. To date, reports of one death and one infection are associated with this recall.
This recall involves all production lots of the following point-of-use (POU) filters, manufactured between July 2011 and September 2013 and distributed between October 2011 and October 2013:
SafeSpout 70-0233, 70-0238
SafeShower HH (Hand Held) 70-0237
SafeShower FH (Fixed Head) 70-0236
BACKGROUND: The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower head.
RECOMMENDATION: If you are in possession of any of the filters identified above, please remove them from use immediately. See the Recall Notice for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the Medwatch safety alert, including a link to the FDA Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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