Events

Rappel de Device Recall DuraMax Chronic Hemodialysis Catheter

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
    59833
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0586-2012
  • Date de mise en oeuvre de l'événement
    2011-01-24
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103834
  • 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
    Angiodynamics received customer complaints for breakage of the tunneler sleeve during product use.
  • Action
    The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). If the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call ANGIODYNAMICS customer service at 1-800-772-6446 or email to: customerservice@angiodynamics.com.

Device

Device Recall DuraMax Chronic Hemodialysis Catheter
  • Modèle / numéro de série
    Lot C28712
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. || The AngioDynamics DuraMax¿ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
  • 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