Events

Rappel de Device Recall MEDRAD Avanta Fluid Management Injection 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 Medrad 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
    59167
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2866-2011
  • Date de mise en oeuvre de l'événement
    2011-06-02
  • Date de publication de l'événement
    2011-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101479
  • 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
    Injector and syringe, angiographic - Product Code DXT
  • Cause
    Event was initially intended to be a product enhancement of the medrad avanta fluid management injection system. upgrades were initiated in october, 2007. observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "important product use reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo.
  • Action
    Medrad Inc., sent two types of "MEDICAL DEVICE FIELD CORRECTION" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have not yet been upgraded through market withdrawal, the notification informed customers that the recalling firm is undertaking a Field Correction to upgrade their system(s). The letter included a step by step guide that will allow customers to verify that their system(s) has NOT been upgraded. Customers are instructed to complete and fax this form to MEDRAD at (412) 406-0941. If you have any questions, concerning these activities contact the Product Manager at (412) 767-2400, extension 8401.

Device

Device Recall MEDRAD Avanta Fluid Management Injection System
  • Modèle / numéro de série
    Catalog numbers: AVA 500 TABL, AVA 500 PEDL
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- (USA) (nationwide) including the state of Puerto Ricoand the countries of: AE, AL, AT, BE, BG, BR, CA, CH, CO, CY, DE, DK, DO, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LY, MA, MT, MX, MY, NL, PA, PH, PK, PT, QA, RS, RU, SA, SE, SG, SI, TR, VI, and ZA.
  • Description du dispositif
    MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL || Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Adresse du fabricant
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA