Events

Rappel de Device Recall Fresenius Optiflux F250NRe Hemodialyzer

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 Fresenius Medical Care Holdings, 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
    60734
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0825-2012
  • Date de mise en oeuvre de l'événement
    2011-12-27
  • Date de publication de l'événement
    2012-01-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106328
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Cause
    Optiflux f250nre hemodialyzers have increased risk of an internal blood leak.
  • Action
    Fresenius Medical Care North America contacted customers by telephone on December 27, 2011, and sent a Customer Notification letter dated December 27, 2011, via certified mail return receipts and fax - back requested to all affected customers. Customers were instructed to examine your stock of dialyzers, and isolate and discontinue use of the before mentioned lots. If you have identified dialyzers from the recalled lots, please contact Customer Service for a Return Goods Authorization. We will pick up the product you currently have in stock and supply replacement product. All products for return will be picked up during your next scheduled Fresenius delivery. Promtly fill out the fax-back reply form attached to the notification. Please do not return used dialyzers. For further questions, please call 1 (800) 662-1237.

Device

Device Recall Fresenius Optiflux F250NRe Hemodialyzer
  • Modèle / numéro de série
    Lot Codes: 8SU203 EXPIRATION DATE: 12/31/2011, 8SU204 EXPIRATION DATE: 12/31/2011, 8SU205 EXPIRATION DATE: 12/31/2011, 09DU02013 EXPIRATION DATE: 04/30/2012, 09DU02014 EXPIRATION DATE: 04/30/2012, 09DU02022 EXPIRATION DATE: 04/30/2012, 09NU02011 EXPIRATION DATE: 10/31/2012, 09PU02011 EXPIRATION DATE: 11/30/2012, 09SU02001 EXPIRATION DATE: 12/31/2012, 09SU02007 EXPIRATION DATE: 12/31/2012, 10AU02013 EXPIRATION DATE: 01/31/2013, 10CU02001 EXPIRATION DATE: 03/31/2013, 10EU02010 EXPIRATION DATE: 05/31/2013, 10EU02017 EXPIRATION DATE: 05/31/2013, 10HU02013 EXPIRATION DATE: 06/30/2013, 10HU02014 EXPIRATION DATE: 06/30/2013, 10LU02001 EXPIRATION DATE: 09/30/2013, 10LU02013 EXPIRATION DATE: 09/30/2013, 10LU02014 EXPIRATION DATE: 09/30/2013, 10LU02015 EXPIRATION DATE: 09/30/2013
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the country of Canada.
  • Description du dispositif
    Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis || Catalog No. 0500325E || The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Adresse du fabricant
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA