Events

Rappel de Device Recall SJM Peel Away Introducer

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 St. Jude Medical.

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
    52457
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1714-2009
  • Date de mise en oeuvre de l'événement
    2009-06-24
  • Date de publication de l'événement
    2009-08-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83082
  • 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
    St. jude medical has initiated a voluntary recall of two lots of peel away introducers . isolated lots could contain some items that have been mis-labelled with the incorrect french size of the outer box label. some 9f products have been labelled as 7f and vice versa. only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product.
  • Action
    The Consignee was provided with a St. Jude Medical "Urgent Product Information" letter and a doctor Acknowledgement form, via e-mail on June 2009. The letter described the problem and the product involved and advised to isolate and discontinue use of the product involved. The Consignee will notify the end user and remove any remaining affected units and will notify St Jude Medical of the results.

Device

Device Recall SJM Peel Away Introducer
  • Modèle / numéro de série
    Lot Number: 2694252.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    OUS only: Belgium.
  • Description du dispositif
    SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO, Rx only. || Intended for use for the introduction of catheters into a vessel.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Adresse du fabricant
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • 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