Events

Rappel de Device Recall SoftVu Angiographic 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 Worldwide Headquarters.

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
    62341
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2180-2012
  • Date de mise en oeuvre de l'événement
    2012-06-15
  • Date de publication de l'événement
    2012-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110292
  • 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, intravascular, diagnostic - Product Code DQO
  • Cause
    Angiodynamics is recalling one lot of soft-vu angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
  • Action
    The firm, AngioDynamics, Inc., sent an "Urgent Medical Device Recall - Immediate Action Required letter dated June 15, 2012 to all consignees/customers via FedEx. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to carefully read this recall notification in its entirety; IMMEDIATELY DISCONTINUE USE OF AND SEGREGATE RECALLED PRODUCT in a secure location for return to AngioDynamics, Inc.; immediately remove recalled product from their inventory; immediately forward a copy of this recall notification to all sites to which they have distributed affected product; and promptly complete, sign and return the Reply Verification Tracking Form (even if you do not have any product to return) via fax to Soft-Vu Angiographic Catheter Recall Coordinator at 1-518-798-1360 or email rdenino@agniodynamics.com. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement. The consignees/customers were also instructed to package and return the recalled product, write the RMA number on the box and send to AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804; Attn: Soft-Vu Angiographic Catheter Recall Coordinator. If you have any questions about this recall action, contact your local Sales Representative or AngioDynamics, Inc. Customer Service Manager at 800-772-6446 or by email at customerservice@angiodynamics.com

Device

Device Recall SoftVu Angiographic Catheter
  • Modèle / numéro de série
    Lot: 564325
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, KS, MO, and NC and countries of: Czech Republic and Switzerland.
  • Description du dispositif
    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. || Intended use: angiographic diagnosis.
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Adresse du fabricant
    Angiodynamics Worldwide Headquarters, 14 Plaza Dr, Latham NY 12110-2166
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA