Events

Rappel de Transhepatic Biliary Stent 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 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
    61713
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1507-2012
  • Date de mise en oeuvre de l'événement
    2012-04-09
  • Date de publication de l'événement
    2012-05-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108774
  • 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, biliary, diagnostic - Product Code FGE
  • Cause
    Cordis corporation is recalling 32 lots of cordis s.M.A.R.T. nitinol stent transhepatic biliary system and s.M.A.R.T. control nitinol stent transhepatic biliary system. there is a potential for a sterility breach due to holes or tears in the tyvek packaging.
  • Action
    Cordis Corp sent a " Urgent Medical Device Recall (Removal) letter dated April 9, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A Response Form was provided with each notification. Customers were asked to complete and return Response Form. The customers were instructed to : " Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. " Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. " Either return any affected product with reference to the RA# on the form, or contact your local sales representative, or contact Customer Service (see Available Assistance section) to facilitate return of the affected product. Replacement product will be provided in a short time frame. Credit will be provided for customer-owned inventory upon request. " Pass on this notice to anyone in your facility that needs to be informed. " If any product listed below has been forwarded to another facility, contact that facility to arrange return. " Maintain awareness of this notice until all product listed above has been returned to Cordis. For questions related to the issue or product replacement, please contact your local sales representative, or contact the special Customer Service number (800) 551-7683, Monday through Friday from 8:30 AM to 8:00 PM EDT.

Device

Transhepatic Biliary Stent System
  • Modèle / numéro de série
    Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698, 15530115, 15536150, 15556366, 15560543, 15530114, 15556368, 15560545, 15562701, 15530113, 15556371, 15560546, 15530112, 15535365, 15556374, 15562702.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-- USA (nationwide) and the country Canada.
  • Description du dispositif
    Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" || Catalog C06120MB Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698. || Catalog C06150MB Lot No's. 15530115, 15536150, 15556366, 15560543. || Catalog C07120 MB Lot No's. 15530114, 15556368, 15560545, 15562701. || Catalog C07150MB Lot No's. 15530113, 15556371, 15560546. || Catalog C08120MB Lot No's. 15530112. || Catalog C08150MB Lot No's. 15535365, 15556374, 15562702. || Indicated for palliation of malignant neoplasms in the biliary tree.
  • 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