Events

Rappel de Distal Access Catheter

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 Concentric Medical 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
    69764
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0525-2015
  • Date de publication de l'événement
    2014-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131488
  • 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, percutaneous - Product Code DQY
  • Cause
    Distal access catheters were shipped to us customers with the directions for use that included instructions for aspiration. this version of the dfu is only approved outside of the us.
  • Action
    The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via Fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, complete form even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.

Device

Distal Access Catheter
  • Modèle / numéro de série
    Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
  • Description du dispositif
    Distal Access Catheter: || Model Numbers: 90121, 90130, 90131, 90160. || The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Adresse du fabricant
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA