BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0488-2014 · Initiated October 28, 2013

    Recall

    Recall Number
    Z-0488-2014
    Event Number
    66736
    Firm
    Nephros Inc
    FEI Number
    3003337893
    Product Code
    ND
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 28, 2013
    Posted
    December 17, 2013
    Terminated
    June 28, 2017
    Address
    41 Grand Ave, River Edge, NJ, 07661-1947

    Description

    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

    Reason

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

    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.

    Distribution

    Nationwide Distribution

    Quantity

    3472 SS units; 513 FH units; 1219 HH units