Events

Rappel de Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 32 cm PreCurve Basic Kit,

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 Angiodynamics, 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
    55701
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1770-2010
  • Date de mise en oeuvre de l'événement
    2010-01-08
  • Date de publication de l'événement
    2010-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91611
  • 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
    Catheter, hemodialysis, implanted - Product Code MSD
  • Cause
    The product has the potential for a cross-lumen leak. one of the two leak testers that are used to perform the leak test on the duramax catheters was found to be faulty. the tester was not able to detect cross-lumen leaks. both testers were used during the manufacturing 100% leak test.
  • Action
    Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.

Device

Device Recall DURAMAX Hemodialysis Catheters, Stack Tip 32 cm PreCurve Basic Kit,
  • Modèle / numéro de série
    Lots 978924, 981851, 981970, C68448, C68449
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and St. Thomas, VI
  • Description du dispositif
    DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog Number/REF 10302814, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Adresse du fabricant
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA