Events

Recall of INSOLARE NASAL CANNULA (INFANT)

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

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
    109383
  • Event Risk Class
    III
  • Event Initiated Date
    2012-04-11
  • 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
    Cannula may cause a false occluded tube alarm on the precision flow at flow rates above 6 lpm (litres per minute).

Device

INSOLARE NASAL CANNULA (INFANT)
  • Model / Serial
    Model Catalog: IMI1300 (Lot serial: all lot codes); Model Catalog: IMI1300B (Lot serial: all lot codes); Model Catalog: IMN1100A (Lot serial: all lot codes); Model Catalog: IMN1100B (Lot serial: all lot codes); Model Catalog: ISOLO1300 (Lot serial: all lot codes)
  • Product Description
    Insolare Nasal Cannula (Infant)
  • Manufacturer
    VAPOTHERM INC.

Manufacturer

VAPOTHERM INC.
  • Manufacturer Address
    EXETER
  • Manufacturer Parent Company (2017)
    Vapotherm Inc.
  • Source
    HC