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Recall Observatory FDA recall evidence

Device 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 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-0488-2014

October 28, 2013

Class I

Product summary

Firm
Nephros Inc
Event
Event 66736
Status
Terminated
Classification
Class I
Quantity
3472 SS units; 513 FH units; 1219 HH units
Official record key
device-enforcement:Z-0488-2014

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 70-0236 and 70-0237 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.