Events

Rappel de Device Recall Subsystem, proportioning

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
    79185
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0811-2018
  • Date de mise en oeuvre de l'événement
    2018-01-29
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161554
  • 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
    May contain endotoxin levels which have been confirmed to exceed the ansi/aami quality standard dialysis fluid of 0.5 eu/ml when used to prepare product.
  • Action
    On January 29, 2018 Product Recall Notices & Recall Reply Forms included were emailed to those patients for whom the firm had an email address. Hard copy letters were sent via UPS second day air to patients for whom NxStage did not have an email address. All Dialysis centers were contacted via email. In addition to the active patients and dialysis center consignees of affected product, recall letters were also emailed to the Dialysis Center Home Training Nurse Manager for all active or dropped patients who were shipped affected product, and corporate contacts for national dialysis accounts. Customers are advised to inspect inventory, quarantine, discontinue use and return product. Customers are also encouraged to return the completed Recall Reply Form. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. Customers with questions may call Customer Service at 1-866-697-8243.

Device

Device Recall Subsystem, proportioning
  • Modèle / numéro de série
    SAK-301- Lot # 70879245, Exp Date 7/11/2019 SAK-302- Lot # 71079056, Exp Date 7/30/2019 SAK-303- Lot #'s 70879181 & 70879224,  SAK-304- Lot #'s 70779236, 70879045, 70879105, 70879220 & 70979066, Exp Date 7/8/2019 SAK-306- Lot # 70979110, Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144, Exp Date 8/27/2019 SAK-402- Lot # 70879235, Exp Date 7/11/2019 SAK-405- Lot #'s 70779202 & 70879233, Exp Date 7/9/2019 SAK-406- Lot #'s 70979253, Exp Date 7/29/2019 SAK-407- Lot #'s 70879236 , Exp Date 7/11/2019
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
  • Description du dispositif
    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 || Hemodialysis systems and accessories
  • 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