The Recall Desk

FDA (Devices) recall action 66736

Nephros Inc recalled 2 products on 2013-12-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-12-25
Critical
0
Units
3,742

Why these products were recalled

Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2013-12-25

    Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing

    Nephros Inc. is recalling SafeSpout water filters because promotional materials made claims that marketed the non-medical products as medical devices.

    Product
    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2013-12-25

    Nephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations

    Nephros Inc. is recalling SafeShower and SafeSpout water filters because promotional materials marketed them as medical devices.

    Product
    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeSho
    Category
    Distribution
    0 states