Events

Rappel de Nephros SafeShower

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Nephros Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66736
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0488-2014
  • Date de mise en oeuvre de l'événement
    2013-10-28
  • Date de publication de l'événement
    2013-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123218
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Nephros SafeShower - Product Code ND
  • Cause
    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.

Device

Nephros SafeShower
  • Modèle / numéro de série
    Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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
  • Manufacturer
    Nephros Inc

Manufacturer

Nephros Inc
  • Adresse du fabricant
    Nephros Inc, 41 Grand Ave, River Edge NJ 07661-1947
  • Société-mère du fabricant (2017)
    Nephros, Inc.
  • Source
    USFDA