FDAFDA · Food and drugs·Recall number Z-0487-2014
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 to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
Published December 25, 2013 · Recall initiated: October 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nephros Inc
- Distributor
- Nationwide Distribution
- Lot
- Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.