Events

Rappel de SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU.

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
    152895
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2010-04-16
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Manufacturer received customer reports of serious adverse health consequences that may be linked to certain cuffed shiley tracheostomy tubes in which the cuff does not hold air(leaks in the pilot balloon inflation assembly.

Device

SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE
  • Modèle / numéro de série
    Model Catalog: DCT (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: PERC (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: MDCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: PERC (Lot serial: 0812000028 TO 0908000232); Model Catalog: DFEN (Lot serial: 0812000028 TO 0908000232); Model Catalog: DCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: MDCT (Lot serial: FOR 10DFEN :); Model Catalog: PERC (Lot serial: FOR 10DFEN :); Model Catalog: DFEN (Lot serial: FOR 10DFEN :); Model Catalog: DCT (Lot serial: FOR 10DFEN :); Model Catalog: MDCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: PERC (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DFEN (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: MDCT (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: PERC (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: DFEN (Lot serial: 0810002453 TO 0908000797 8PERC); Model C
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUB
  • Manufacturer
    COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU

Manufacturer

COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU
  • Adresse du fabricant
    BOULDER
  • 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
    HC