Events

Rappel de Merit 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
    69452
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0162-2015
  • Date de publication de l'événement
    2014-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130706
  • 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
    These microcatheters were packaged with a 2.8 f distal tip, rather than the labeled 2.4 f.
  • Action
    Consignees were notified via letter on September 26, 2014. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to US Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account, a representative copy of communications sent directly to their affected accounts, and a copy of the Frequently Asked Questions. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department.

Device

Merit Maestro Microcatheter
  • Modèle / numéro de série
    Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and to India. No govt/military/VA consignees.
  • Description du dispositif
    Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
  • 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