Events

Rappel de CROSSOVER Sheath 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 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
    53574
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0087-2010
  • Date de mise en oeuvre de l'événement
    2009-10-15
  • Date de publication de l'événement
    2009-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85892
  • 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
    Introducer, catheter - Product Code DYB
  • Cause
    Cordis has received complaints of stretching or fracture of the sheath shaft during use.
  • Action
    A Medical Device Recall letter dated October 19, 2009 was issued to consignees by sending an overnight letter to each account. The letter described the affected device, issue and actions for customers. A Cordis Corporation representative will follow-up and contact consignees as necessary to facilitate obtaining signature, faxing the acknowledgement form to the Cordis Corporation, collecting and returning units. A press release from the Cordis Corporation announced a nationwide recall of the CROSSOVER Sheath Introducer available on (http://www.webwire.com/ViewPressRel.asp?aId=106460). In addition to the local sales representative, customers may contact the special Customer Service number at 1-866-854-1672, Monday through Friday from 8:30 a.m. to 8:00 p.m. Eastern Standard Time, if you have any additional questions relative to product return or alternate product.

Device

CROSSOVER Sheath Introducer
  • Modèle / numéro de série
    Catalog Number: 403545S, Lot Numbers: U0000027, U0000041 and U0000047;  Catalog Number: 403585S, Lot Number U0000025;  Catalog Number: 403645S, Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052;  Catalog Number: 403685S, Lot Numbers U0000033, U0000042 and U0000050;  Catalog Number: 403745S, Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and  Catalog Number: 403785S, Lot Numbers U0000037 and U0000046.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.
  • Description du dispositif
    Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. || Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA || Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. || The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Adresse du fabricant
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA