Events

Rappel de Device Recall ASP Automatic Endoscope Reprocessor (AER)

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
    57281
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0628-2011
  • Date de mise en oeuvre de l'événement
    2010-02-19
  • Date de publication de l'événement
    2010-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95737
  • 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 and/or accessories - Product Code KOG
  • Cause
    The recall was initiated because advanced sterilization products (asp) received three customer reports of elevated temperature of the high-level disinfectant solution used in the asp aer as a result of a possible temperature monitoring system malfunction. this recall communication advised consignees that if high-level disinfectants are exposed to elevated temperatures, fumes may occur and resul.
  • Action
    Advanced Sterilization Products sent an URGENT: PRODUCT CORRECTION letter dated February 19, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall communication was initiated with ASP forwarding a "Urgent: Product Correction" letter with attached customer fax-back response form to the affected customers. Customers were also instructed to complete and sign the enclosed customer fax-back response form indicating that they have disconnected the heater on the ASP AER according to the instructions provided and fax the form to 1-888-345-1435. If customers have any questions or need assistance, they were instructed to call ASP Professional Services at 888-783-7723, option 3 then option 1.

Device

Device Recall ASP Automatic Endoscope Reprocessor (AER)
  • Modèle / numéro de série
    Product Code: 20300 & 20301
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Argentina Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Hungary, Mexico, Panama, Guatemala, Honduras, Poland, Puerto Rico, Virgin Islands, Singapore, Taiwan, Venezuela, Croatia, and Bulgaria.
  • Description du dispositif
    ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 || The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

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