Events

Rappel de PORTACATH and PORTACATH II implantable venous and arterial access systems

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 Smiths Medical ASD, Inc..

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
    66234
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2269-2013
  • Date de mise en oeuvre de l'événement
    2013-09-10
  • Date de publication de l'événement
    2013-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121807
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Cause
    Smiths medical is conducting a voluntary recall of port-a-cath¿ and port-a-cath¿ ii implantable venous and arterial access systems and introducer sets. smiths medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these sets. smiths medical has received no reports.
  • Action
    Smiths Medical ASD, Inc. sent an Urgent Field Safety Notice dated September 6, 2013, to all affected customers. The letter described the problem and the product involved in the recall. The letter included the "Advice on Action to be Taken by the User" which instructed consignees to inspect and remove affected devices and to complete and return the "Urgent Field Safety Notice Confirmation Form. The letter also included information on the "Transmission of this Urgent Field safety Notice" which included information where customers should report issues related to the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions on the information provided they should contact 800-258-5361 (Smiths Medical's Customer Service Department). For questions regarding this recall call 1-800-332-0178.

Device

PORTACATH and PORTACATH II implantable venous and arterial access systems
  • Modèle / numéro de série
    21-8011-24:  1971567 1979805 1984078 1997124 2006124 2038001 2090898 2151160 2196530 2216256 2249695  21-8052-24:  1971572 2012472 2022904 2067947 2080704 2146472 2168988 2196532 2207404 2237458 2249696 2269178 2282158  21-8053-24:  2168989 2249697
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.
  • Description du dispositif
    Smiths Medical, Deltec: || REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. || REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. || Sterile EO, Rx Only. || PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA