S100 Sink Spout 70-0280Recalls & reported problems

Nephros, Inc. · The S100 Point of Use Filter is a disposable point-of-use micro-filter used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon’s hands. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896241002541), received between Aug 26, 2022 and Aug 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Break2
Filtration Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 26, 2022Break; Filtration Problem; Break; Filtration Problem
ON (B)(6) 2022 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF AN S100 POINT OF USE (70-0280) FILTER ON ONE OF THEIR SINKS. THERE WAS NO REPORTED ADVERSE EVENT. NEPHROS S100 POINT OF USE IS A SINK WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED ON SINK FAUCETS IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA. THE USER FACILITY ROUTINELY TESTS THEIR WATER AT THEIR SINKS AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY IMPROPER INSTALLATION, CROSS CONTAMINATION AND/OR A BREACH OF THE FILTER MEMBRANE. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES AND THE INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15307026 ↗
MalfunctionAug 26, 2022Break; Filtration Problem; Break; Filtration Problem
ON (B)(6) 2022 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF AN S100 POINT OF USE (70-0280) FILTER ON ONE OF THEIR SINKS. THERE WAS NO REPORTED ADVERSE EVENT. NEPHROS S100 POINT OF USE IS A SINK WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED ON SINK FAUCETS IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA. THE USER FACILITY ROUTINELY TESTS THEIR WATER AT THEIR SINKS AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY IMPROPER INSTALLATION, CROSS CONTAMINATION AND/OR A BREACH OF THE FILTER MEMBRANE. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES AND THE INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15307007 ↗

Device details

UDI-DI	`00896241002541`
Brand	S100 Sink Spout
Model	70-0280
Company	Nephros, Inc.
Product code	NHV · System, Water Purification, General Medical Use
Class	Class 2
FDA submission	K153084
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Feb 14, 2024

Device type (GMDN): Microbial water purification filter, non-sterilizable

A sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.

Other System, Water Purification, General Medical Use devices

DSU-H Quick Connect 70-0285
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4 reports
Nephros DSU-H UltraFilter 70-0285
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1 report

All System, Water Purification, General Medical Use devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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