Events

Rappel de Device Recall NxStage Dialysate Sack (SAK) with Concentrate

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
    68354
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1854-2014
  • Date de mise en oeuvre de l'événement
    2014-05-14
  • Date de publication de l'événement
    2014-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127450
  • 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
    Dialysate Subsystem, proportioning - Product Code FKR
  • Cause
    Sak dialysate concentrate contain aluminum levels which exceed internal product specification.
  • Action
    NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).

Device

Device Recall NxStage Dialysate Sack (SAK) with Concentrate
  • Modèle / numéro de série
    Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Description du dispositif
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-301 || Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 100, Glucose (mg/dL) 100 || Batch Size (liters) 60 || The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Adresse du fabricant
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • Société-mère du fabricant (2017)
    Nxstage Medical Inc
  • Source
    USFDA