Events

Rappel de Getinge Assure

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 Getinge USA Inc.

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
    65866
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1994-2013
  • Date de mise en oeuvre de l'événement
    2013-08-02
  • Date de publication de l'événement
    2013-08-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120574
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Cause
    Accufast biological indicator lot sr-430 may have been exposed to conditions affecting its viability. this could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
  • Action
    GETINGE sent an DEVICE CORRECTION NOTICE letter dated July 31, 2013, and response forms were sent to customers on August 2, 2013, via Certified Mail Return Receipt Requested. The letters instruct customers to immediately discontinue use, quarantine, and destroy the affected lot. In addition, they instruct customers to: Check the appropriate box and record the quantity of affected unused product on the enclosed Correction Response Form OR If if they do not have any lots of affected unused inventory check the box indicating such. Destroy the unused product in accordance with your institution's policy and instructions for use. Record the method of destruction on the Correction Response Form. Be sure to include the Facility Name, Address, Contact Name and Phone Number. Sign, date and e-mail the form back to SR430responseform@getinge.com within 10 days or sooner of receiving this notice. Credit will be issued upon receipt of the Correction Response Form. Replacement product of unaffected lots is currently available. The warehouse shipping the affected lot is no longer being used (due to business decision, not as result of this recall). The current warehouse is maintaining the product in a controlled temperature segregated room away from any potential sterilants. If you have any questions regarding this notification please call 1-800-475-1400 ext. 5026

Device

Getinge Assure
  • Modèle / numéro de série
    LOT SR-430 (Expiration 02/06/2014)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the country of Canada.
  • Description du dispositif
    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. || Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
  • Manufacturer
    Getinge USA Inc

Manufacturer

Getinge USA Inc
  • Adresse du fabricant
    Getinge USA Inc, 1777 E Henrietta Rd, Rochester NY 14623-3133
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA