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Recall Observatory FDA recall evidence

Device 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 to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

Z-0487-2014

October 28, 2013

Class I

Product summary

Firm
Nephros Inc
Event
Event 66736
Status
Terminated
Classification
Class I
Quantity
3742 units
Official record key
device-enforcement:Z-0487-2014

Official wording

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

Code information: Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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