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
    61329
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1333-2012
  • Date de mise en oeuvre de l'événement
    2012-02-16
  • Date de publication de l'événement
    2012-03-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107810
  • 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
    Co2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
  • Action
    Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.

Device

Device Recall Oridion
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Oridion CO2 sampling lines and water traps under the label: || Omnistream CO2 Sampling Lines: || OmniLine O2 Adult Part No.007609; || OmniLine O2 Pediatric Part No 007610; || Smart OmniLine Plus O2 Adult Part No.010177; || Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; || Smart OmniLine O2 Pediatric Part No. 007606; || ;Smart OmniBloc O2 Part No. 010946 || Smart OmniLine Plus part No. 010172 || Smart OmniLine Plus (package of 100 units) Part No 010212; || Smart OmniLine Guardian O2 Part No. 012531; || Smart OmniLine Guardian O2 Long Part No. 012532 || OmniVentLine Set Part No. 012495
  • 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