Events

Rappel de Device Recall McGrath MAC2 Video Laryngoscope Blades

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 Aircraft Medical Limited.

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
    69805
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0494-2015
  • Date de mise en oeuvre de l'événement
    2014-11-04
  • Date de publication de l'événement
    2014-12-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131569
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Cause
    The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.
  • Action
    Aircraft Medical Limited sent a recall notification letter dated November 4, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its own stock and its customers' stock for the recalled products; 2) arrange for any remaining stock to be removed from use. Customers with any questions can contact Aircraft Medical by e-mail at ac@aircraftmedical.com.

Device

Device Recall McGrath MAC2 Video Laryngoscope Blades
  • Modèle / numéro de série
    Product Code: 350-017-000.   Lot Numbers and Expiration Dates: Lot 13121202, Expires 2016/12/11; Lot 13122301, Expires 2016/12/25; Lot 13042401, Expires 2017/5/5; Lot 14030501, Expires 2017/3/16; Lot 14031814, Expires 2017/3/26; Lot 14061616, Expires 2017/6/25.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
  • Description du dispositif
    McGrath MAC2 Video Laryngoscope Blades || Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. || Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
  • Manufacturer
    Aircraft Medical Limited

Manufacturer

Aircraft Medical Limited
  • Adresse du fabricant
    Aircraft Medical Limited, 9-10 SAINT ANDREW SQUARE, EDINBURGH United Kingdom
  • 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