Events

Rappel de Device Recall EvoTech Endoscope Cleaner & Reprocessor

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 Advanced Sterilization Products.

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
    46906
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1369-2008
  • Date de mise en oeuvre de l'événement
    2008-02-13
  • Date de publication de l'événement
    2008-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68458
  • 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
    Endoscope Washer/Disinfector - Product Code FEB
  • Cause
    Cleaning cycles are being cancelled. specific issues are: a) water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) interface board malfunction resulting in a premature lid opening, and c) minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
  • Action
    Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs.

Device

Device Recall EvoTech Endoscope Cleaner & Reprocessor
  • Modèle / numéro de série
    Product Code 50004-002; Serial Numbers 50004002070001 and 50004002070004
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada and Japan.
  • Description du dispositif
    EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 || Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Adresse du fabricant
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA