Events

Rappel de QUADROX Oxygenator

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 Maquet Cardiovascular Us Sales, Llc.

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
    66049
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2262-2013
  • Date de mise en oeuvre de l'événement
    2013-08-15
  • Date de publication de l'événement
    2013-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121375
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Cause
    The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
  • Action
    Maquet sent a Urgent Product Recall letter/Response Form, dated 8/15/2013 via Fed Ex. On 8/26/2013 Maquet sent a letter to their customers informing them that all shipments of oxygenators and stainless steel hold clamps have been placed on a temporary hold due to an agency review in connection with FDA clearance. Customer service may be contacted at 1-888-627-8383, (option 2 followed by option 2) Monday though Friday between the hours of 8:00 am and 6:00 pm EST. Maquet issued a Certificate of Medical Neccesity (CMN) on September 17, 2013 to notify Quadrox customers that they may continue to receive and use their current inventory of Quadrox oxygenators and clamps by acknowledging the conditions provided in the CMN.

Device

QUADROX Oxygenator
  • Modèle / numéro de série
    QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult catalog number VKMO 70000, lot # 70082663 QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution, including Nationwide (US) and foreign countries.
  • Description du dispositif
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Adresse du fabricant
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA