Events

Rappel de Device Recall S.M.A.R.T. Flex Biliary/Vascular selfexpanding 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
    78674
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0324-2018
  • Date de mise en oeuvre de l'événement
    2017-11-15
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160097
  • 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
    Stents, drains and dilators for the biliary ducts - Product Code FGE
  • Cause
    Potential for cracked luer hubs.
  • Action
    On November 15, 2017 the firm sent letter to their customers indicating the following: The purpose of this communication is to inform you of a potential leakage scenario with the S.M.A.R.T.¿ Flex Biliary Stent System. The leak may occur due to potentially cracked hubs in some units from within the 29 lots listed in this letter. Inspection details: As stated in the Instructions for use, users are warned that the device should not be used if the outer sheath cannot be flushed. Inspect for leakage during preparation of the device. Leakage may be more likely in the affected product due to cracks in the luer. At time of actual flushing, if there is no leakage observed, the product may be safely used. Available Assistance: We can provide help if you have any questions regarding this Correction. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365.

Device

Device Recall S.M.A.R.T. Flex Biliary/Vascular selfexpanding stent system
  • Modèle / numéro de série
    GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352,  20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and  20705032066317 SF10100MB 41058.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.
  • Description du dispositif
    Cordis S.M.A.R.T. Flex Biliary Stent System || Product Usage: || Is indicated for use in the palliation of malignant strictures 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