Events

Rappel de Device Recall NXStage PureFlow SL SAK303

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 NxStage Medical, 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
    60807
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0826-2012
  • Date de mise en oeuvre de l'événement
    2011-12-14
  • 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
    2012-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106520
  • 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
    Subsystem, proportioning - Product Code FKR
  • Cause
    Report of high conductivity failure alarms with the pureflow sl due to excess concentrate by weight in the product (sak) dialysate preparation system.
  • Action
    On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided. If you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).

Device

Device Recall NXStage PureFlow SL SAK303
  • Modèle / numéro de série
    Lot 1117911, Exp. 2013-09
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx || The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Adresse du fabricant
    NxStage Medical, Inc., 439 S Union St Fl 5th, Lawrence MA 01843-2837
  • Société-mère du fabricant (2017)
    Nxstage Medical Inc
  • Source
    USFDA