Events

Rappel de Device Recall STERRAD NX Sterilizer

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
    51146
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0468-2012
  • Date de mise en oeuvre de l'événement
    2008-12-10
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78821
  • 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
    Sterilizer, chemical - Product Code MLR
  • Cause
    Advanced sterilization products (asp) has discovered a defect in the barcode labeling of the sterrad nx system cassettes 10133, lot #08i032. this is the only lot number affected by this action. the barcodes for lot #08i032 were printed improperly and are not capable of being read by the sterrad unit.
  • Action
    Advance Sterilization Products sent an "URGENT: PRODUCT RECALL" letter dated December 10, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine inventory and return all sealed cassettes, using an enclosed prepaid UPS return label to: Stericycle, 2670 Executive Drive Suite A, Indianapolis, IN 46241. Additionally, a Business Reply Card and packing slip were included with the letter for customers to complete and return. Questions or further assistance was directed to ASP Customer Care Center at 888-783-7723, option 2.

Device

Device Recall STERRAD NX Sterilizer
  • Modèle / numéro de série
    Product Code 10133; Lot #081032
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. || The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
  • 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