Events

Rappel de Device Recall Medex 2000

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 Medex 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
    26633
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1060-03
  • Date de mise en oeuvre de l'événement
    2003-06-09
  • Date de publication de l'événement
    2003-07-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-03-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28036
  • 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
    unknown device name - Product Code CAJ
  • Cause
    Inadequate warning label as pertains to use of the pump in conjunction with extracorporeal membrane oxygenation (ecmo) procedures.
  • Action
    Consignees were notified via letter dated June, 2003. The firm provided each consignee with a warning label to be affixed to all pump and to the front cover of the Instruction Manual.

Device

Device Recall Medex 2000
  • Modèle / numéro de série
    Series #2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T, 2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010iK, 2010iVX, 2010iZE
  • Distribution
    Units were distributed to medical facilities nationwide and worldwide.
  • Description du dispositif
    Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, ''VX in the suffix means it is an evaluation pump, ''NFHU is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software. They are refurbished or upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Adresse du fabricant
    Medex Inc, 4350 River Green Parkway, Suite 200, Duluth GA 30096
  • Source
    USFDA