Events

Rappel de Device Recall Maestro Microcatheter

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 Merit Medical Systems, 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
    67128
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0614-2014
  • Date de mise en oeuvre de l'événement
    2013-12-06
  • Date de publication de l'événement
    2013-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124756
  • 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, continuous flush - Product Code KRA
  • Cause
    Merit medical systems, inc. is conducting a recall for 3 lots of maestro microcatheters with a graphic discrepancy on the carton/box label end panel. the catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
  • Action
    Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.

Device

Device Recall Maestro Microcatheter
  • Modèle / numéro de série
    Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Description du dispositif
    Catheter, Continuous Flush || The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Adresse du fabricant
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Société-mère du fabricant (2017)
    Merit Medical Systems Inc
  • Source
    USFDA