Events

Rappel de Device Recall Guidant RAPIDO CutAway Guiding 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 Abbott Vascular.

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
    58979
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2793-2011
  • Date de mise en oeuvre de l'événement
    2011-01-07
  • Date de publication de l'événement
    2011-07-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100794
  • 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
    Cardiovascular Guiding Catheter - Product Code DQY
  • Cause
    Five lots of guide catheters and accessory products were processed through ethylene oxide (eto) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for eto sterilization.
  • Action
    Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product

Device

Device Recall Guidant RAPIDO CutAway Guiding Catheter
  • Modèle / numéro de série
    Lot Number: 0120891 and 0121091
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution, and Ireland.
  • Description du dispositif
    Guidant RAPIDO Cut-Away Guiding Catheter, 6F. || Part Numbers: 66676-201 and 667552-100. || For use in cardiac diagnostic and therapeutic procedures.
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Adresse du fabricant
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA