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U.S. Department of Health and Human Services

Class 1 Device Recall Nephros SafeSpout

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 Class 1 Recall
Nephros SafeSpout
see related information
Date Posted December 17, 2013
Recall Status1 Open
Recall Number Z-0487-2014
Recall Event ID 66736
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
Code Information Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
Recalling Firm/
Manufacturer
Nephros Inc
41 Grand Ave
River Edge, New Jersey 07661-1947
For Additional Information Contact Ms. Eileen Sukumaran
201-343-5202
Manufacturer Reason
for Recall
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
FDA Determined
Cause 2
DESIGN: Device Design
Action Nephros sent an Urgent Medical Device Recall letter dated October 28, 2013, with a return response form to all affected customers via UPS 2nd Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease shipment of the affected product immediately. Obtain an RGA number to return the new and used filters for credit. In addition, customers were instructed to immediately remove and discard all copies of the labeling materials that pertain to the affected product. Remove all electronic copies of these materials from any publicly accessible locations (e.g. website). Customers with questions were instructed to contact their Nephros representative or call 201-343-5202, ext 100. For questions regarding this recall call 201-343-5202. The letter was also posted at: http://www.nephros.com/download/news/SafeSpout_SafeShower_Recall_Letters.pdf Nephros sent a new recall letter dated 2/20/204 as they determined they have additional customers.
Quantity in Commerce 3742 units
Distribution Nationwide Distribution

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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