Events

Rappel de AQUAVENT LIMB FOR OXYGEN THERAPY ADULT HEATED

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARESTREAM MEDICAL 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
    144629
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-09-28
  • 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
    Armstrong medical ltd is investigating the heater wire retainer (located in the heated limbs of adult corrugated heated ventilator and cpap breathing circuits as a means to locate the heater wire in a fixed position). the retainer is white or off-white in color and made from polymeric (plastics) material. if breakage of this component were to occur there could be a possible inhalation risk to the patient.

Device

AQUAVENT LIMB FOR OXYGEN THERAPY ADULT HEATED
  • Modèle / numéro de série
    Model Catalog: AMCP1409/004 (Lot serial: 080310 TO 310812); Model Catalog: AMCPSI01052 (Lot serial: 080310 TO 310812); Model Catalog: AMCPUK01103 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1792/130 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/101 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/102 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/105 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/106 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/101 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/102 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/106 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/108 (Lot serial: 080310 TO 310812); Model Catalog: AMCPUK01109 (Lot serial: 080310 TO 310812); Model Catalog: AMCP1409/003 (Lot serial: 080310 TO 310812)
  • Description du dispositif
    AQUABENT LIMB FOR OXYGEN THERAPY ADULT HEATED
  • Manufacturer
    CARESTREAM MEDICAL LTD

Manufacturer

CARESTREAM MEDICAL LTD