Events

Rappel de Device Recall ACCUCHEK Tender II Infusion Set

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 Diagnostics Operations, 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
    69821
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0894-2015
  • Date de mise en oeuvre de l'événement
    2014-11-20
  • Date de publication de l'événement
    2014-12-30
  • Statut de l'événement
    Terminated
  • 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=131598
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Roche diabetes care was informed by unomedical, the manufacturer of accu-chek tender i and accu-chek tender ii infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the accu-chek tender i and accu-chek tender ii infusion sets. if tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify.
  • Action
    Roche sent the "Urgent Medical Device Corrections" letter dated 12/1/2014 via UPS Ground (receipt required) to the Patients, and Distributors who received the affected device. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Pump Support at 1-800-688-4578.

Device

Device Recall ACCUCHEK Tender II Infusion Set
  • Modèle / numéro de série
    Catalog: 04541499001 and lots: 5051307, 5061935, and 5078667.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    ACCU-CHEK Tender II 17/110 10 + 10 pieces || Product Usage: || Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA