Events

Rappel de Device Recall STERRAD 200 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
    47355
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1630-2008
  • Date de mise en oeuvre de l'événement
    2008-02-25
  • 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
    2011-11-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69274
  • 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
    Chemical Sterilizer - Product Code MLR
  • Cause
    Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke.".
  • Action
    The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do if they experience a filter failure - a) cancel the cycle if the sterilizer is running [and as always, do not use instruments from an incomplete cycle], b) leave the room, c) discontinue use of the STERRAD Sterilizer until the system is repaired. d) Personnel should avoid working in the room until the mist has cleared. The letter advises that ASP service will replace the sterilizer's filter and increase the frequency of filter changes by adjusting the Planned Maintenance (PM) schedule within the software on their STERRAD 100S and STERRAD NX Sterilizer. Per the notice, for each STERRAD Sterilizer model, ASP will do the following: a) STERRAD 200 Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter and gasket assembly at no charge. b) STERRAD NX Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter assembly at no charge and adjust the PM schedule to 650 cycles or 6 months (whichever occurs first). c) STERRAD 100S Sterilizer - beginning April 28, 2008 through October 2008, ASP will adjust the PM schedule to 750 cycles or 6 months (whichever occurs first). d) STERRAD 50 and 100NX Sterilizers - No adjustments to the oil mist filters or PM schedules are required at this time. PMs will be performed as currently scheduled. Information for MedWatch reporting is included in the letter.

Device

Device Recall STERRAD 200 Sterilizer
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Peru, Canada, Czech Republic, Middle East, Portugal, S. Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
  • Description du dispositif
    STERRAD 200 Sterilization System, Product Code 10201 || 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 Dr, Irvine CA 92618-2346
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA