FDAClass IDecember 25, 2013

1) Nephros SafeShower FH - 15 filters per box recall

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…

Why was 1) Nephros SafeShower FH - 15 filters per box recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

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…
Recalling firm
Nephros Inc
Quantity
3472 SS units; 513 FH units; 1219 HH units
Distribution
Nationwide Distribution
Recall date
December 25, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls