Events

Rappel de Device Recall Cordis

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 Cordis Corporation.

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
    27138
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0565-04
  • Date de mise en oeuvre de l'événement
    2003-08-29
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29261
  • 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
    Forceps, General & Plastic Surgery - Product Code GEN
  • Cause
    Some devices may have an incorrect inner label which shows product # 504302l with a length of 50cm, while the outer label is correctly labeled as product # 504300l with the length of 104cm.
  • Action
    The firm initially sent Cordis representatives to visit all 21 domestic accounts the week of August 25, 2003. Follow-up Recall notificaiton Letters were sent to each account discussing the problem and informing them that a Cordis Representative has been at their location and inspected their product for misbranded devices. In 18 cases the letter stated that NO mislabeled product was found but in three other cases they were told that mislabeled product was found and recovered. These follow-up letters to the visits were sent out on August 29, 2003. A similar inspection was performed by Cordis Representatives for International Accounts and the Recall Notification was sent to the International Accounts on 8/29/2003.

Device

Device Recall Cordis
  • Modèle / numéro de série
    Lot Number 70403255
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The devices were distributed to 21 domestic hospital accounts in MI, OK, FL, TN, NY, IN, VA, NC, WI, GA, IA, NE, CA. Also product was distributed to International Distributors in the Netherlands, Canada and Mexico.
  • Description du dispositif
    Cordis Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Adresse du fabricant
    Cordis Corporation, 14201 N.W. 60th Ave, Miami Lakes FL 33014
  • Source
    USFDA