Events

Rappel de Device Recall HydroFinity Guidewire

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 Nitinol Devices and Components, 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
    68419
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1818-2014
  • Date de mise en oeuvre de l'événement
    2014-05-28
  • Date de publication de l'événement
    2014-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127558
  • 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
    Wire, guide, catheter - Product Code DQX
  • Cause
    Reports of outer polymer jacket to the core wire being damaged during use on the hydrofinity guidewire.
  • Action
    Covidien sent an Urgent Product Recall letter dated May 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused devices to Covidien, their account would be credited. Customers were also instructed to:: 1) Stop using product listed in this letter immediately 2) Segregate this product from other inventory 3) Fill out the reply (verification) form at the end of this letter ¿ If you do not have any product identified in this letter, please fax or email the completed form to Covidien at (877) 523-9109 or covidien8770@stericycle.com. ¿ If you do have product, your sales representative will assist you in completing the verification form and arranging for return of the product. ¿ Please fax the completed form to Covidien (877) 523-9109 or email to covidien8770@stericycle.com. 4) Your sales representative will be available to answer any questions regarding this recall and assist you in completing the verification form, returning product and addressing any account credits. This action is being conducted with the knowledge of the United States FDA and other regulatory authorities. ¿ Customers with questions were instructed to call (202) 310-5120. For questions regarding this recall call 202-310-5120. _

Device

Device Recall HydroFinity Guidewire
  • Modèle / numéro de série
    Model HPSA35150- all lots.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Description du dispositif
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.

Manufacturer

Nitinol Devices and Components, Inc.
  • Adresse du fabricant
    Nitinol Devices and Components, Inc., 47533 Westinghouse Dr, Fremont CA 94539-7463
  • Société-mère du fabricant (2017)
    Nitinol Devices and Components, Inc.
  • Source
    USFDA