Z-0490-2014Class I

Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2

Name: Z-0490-2014 Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2
Creator: Nephros Inc
Published: 2013-10-28
License: https://open.fda.gov/license/

Nephros Inc / initiated 2013-10-28 / Terminated / root cause: labeling and UDI

FDA source

Nephros Inc began a recall of 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... on 2013-10-28. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0490-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-12-17
Terminated: 2016-07-06
Recalling firm: Nephros Inc
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.
Reason for recall: Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Nephros Inc., sent an Urgent Medical Device Recall letter dated October 29, 2013 to all affected customers via UPS 2nd Day Air. The letter identified the affected product, problem and actions to be taken. Customer are asked to provide a customer information list, immediately remove and discard all affected product labeling materials and any independent labeling materials they have created for the affected products. Customers are instructed to complete and sign the attached Response Form to acknowledge receipt, understanding and compliance with the instruction. For questions contact the Nephros representative at 201-343-5202 x 100. The letter was also posted at : http://www.nephros.com/download/news/DSU_Recall_Letters.pdf
Quantity in commerce: 3,367 untis with affected labeling
Distribution: USA Nationwide Distribution
Product codes and lots: Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0490-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0490-2014	Class I	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)