Events

Rappel de Device Recall ACCUCHEK FlexLink Plus

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 Roche Insulin Delivery Systems 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
    58015
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1483-2011
  • Date de mise en oeuvre de l'événement
    2011-02-24
  • Date de publication de l'événement
    2011-03-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97979
  • 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
    Infusion Pump - Product Code FRN
  • Cause
    There is the potential to kink or bend the cannula when inserting the accu-chek flexlink plus infusion set. this can lead to under delivery and elevation of blood glucose levels.
  • Action
    Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.

Device

Device Recall ACCUCHEK FlexLink Plus
  • Modèle / numéro de série
    Part Number: 05510970001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK. || An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. || Made in Germany || Manufactured for and Distributed by || Roche Insulin Delivery Systems Inc. || Fishers, IN 46037, USA || Toll Free: 1-800-280-7801 || Roche Diabetes Care AG || 3401 Burgdorf, Switzerland
  • Manufacturer
    Roche Insulin Delivery Systems Inc.

Manufacturer

Roche Insulin Delivery Systems Inc.
  • Adresse du fabricant
    Roche Insulin Delivery Systems Inc., 11800 Exit 5 Pkwy Ste 120, Fishers IN 46037-7989
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA