Events

Rappel de Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm

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 Steris Corporation Hopkins Facility.

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
    60742
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0869-2012
  • Date de mise en oeuvre de l'événement
    2011-12-07
  • Date de publication de l'événement
    2012-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106373
  • 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
    Sterilant, medical devices - Product Code MED
  • Cause
    Software deficiency. steris identified that water specifications were not being met at some of their customer sites. critical parameters for initiating cycles are: water quality, water pressure and water temperature. failure to meet these criteriae may lead to cycle aborts by the system 1e liquid chemical sterilant processing system. the firm intends to perform a software field correction which.
  • Action
    The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM ¿¿ Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.

Device

Device Recall SYSTEM 1E Liquid Chemical Sterilant Processing Systm
  • Modèle / numéro de série
    MED. Serial Numbers: 400000 through 405499 are subject to correction.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
  • Description du dispositif
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • Manufacturer
    Steris Corporation Hopkins Facility

Manufacturer

Steris Corporation Hopkins Facility
  • Adresse du fabricant
    Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
  • Société-mère du fabricant (2017)
    Steris Plc
  • Source
    USFDA