Events

Recall of AQUAVENT LIMB FOR OXYGEN THERAPY ADULT HEATED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM MEDICAL LTD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    144629
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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)
  • Product Description
    AQUABENT LIMB FOR OXYGEN THERAPY ADULT HEATED
  • Manufacturer
    CARESTREAM MEDICAL LTD

Manufacturer

CARESTREAM MEDICAL LTD