Events

Rappel de Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems

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 Renal Therapies Group, LLC.

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
    73487
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1325-2016
  • Date de mise en oeuvre de l'événement
    2016-03-10
  • Date de publication de l'événement
    2016-04-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144284
  • 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
    Added warning statement: fresenius 2008 series hemodialysis machines false blood leak alarm when dialyzing patients treated with hydroxocobalamin (or any form of vitamin b-12).
  • Action
    Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008¿ Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572.

Device

Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems
  • Modèle / numéro de série
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: || Models: || Fresenius 2008K and 2008K2 Dialysate Delivery System || Fresenius 2008K@home Hemodialysis Machine with bibag System || 2008T Hemodialysis Machine || The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • Adresse du fabricant
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA