Events

Rappel de Polyflux Revaclear, Capillary Dialyzer

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 Gambro Renal Products, Incorporated.

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
    67996
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1643-2014
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Date de publication de l'événement
    2014-05-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126755
  • 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
    The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
  • Action
    The recall was initiated by an Urgent: Medical Device Recall letter delivered by UPS Overnight Delivery on April 16, 2014. The letter identified the affected product and reason for the recall. The firm is asking customers to remove and quarantine any remaining affected product from their inventory for collection and replacement. Customers are to also complete and return the Customer Reply Form to the Gambro Regulatory Affairs Department. Customers with affected product are to contact Gambro Customer Support or their Gambro representative to return the product. Questions should be directed to Customer Support at 1-800-651-2623.

Device

Polyflux Revaclear, Capillary Dialyzer
  • Modèle / numéro de série
    Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
  • Description du dispositif
    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; || Gambro Renal Products, Inc. || Intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
    Gambro Renal Products, Incorporated

Manufacturer

Gambro Renal Products, Incorporated
  • Adresse du fabricant
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA