Events

Rappel de Device Recall UNIFUSE INFUSION SYSTEM

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
    59820
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3266-2011
  • Date de mise en oeuvre de l'événement
    2011-01-28
  • Date de publication de l'événement
    2011-09-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103805
  • 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, continuous flush - Product Code KRA
  • Cause
    The particular lots of unifuse catheters were packaged with the wrong occluding ball guidewires.
  • Action
    URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should be directed towards customers' local sales representative or call Julie Blair, Customer Service Manager at 1-800-772-6446.

Device

Device Recall UNIFUSE INFUSION SYSTEM
  • Modèle / numéro de série
    Lot 521388 (Use By 2013-07)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and The Netherlands.
  • Description du dispositif
    ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 10 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Adresse du fabricant
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA