Events

Rappel de Device Recall Oridion

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 Oridion Medical 1987 Ltd..

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
    61143
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1350-2012
  • Date de mise en oeuvre de l'événement
    2011-12-01
  • Date de publication de l'événement
    2012-03-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107389
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    Surestream co2 sampling lines-connector may cause breakage of the microswitch inside the co2 inlet.
  • Action
    Oridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at technicalsupport@oridion.com

Device

Device Recall Oridion
  • Modèle / numéro de série
    Lot Numbers: M8337N10, M8507A11, M8552B11
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
  • Description du dispositif
    Oridion Surestream CO2 Sampling Lines- || Sure VentLine H Set Adult/Pediatric || Part Number: 010987-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • Adresse du fabricant
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA