Events

Recall of PARAGON OXYGENATOR

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

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
    143206
  • Event Risk Class
    III
  • Event Initiated Date
    2017-09-14
  • 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
    Due to the coating used on the paragon oxygenators the classification originally assigned to the oxygenators (class ii) is to be amended to a class iv. until the class iv application had been processed manufacturer would voluntarily cease sale of the paragon oxygenators. this does not affect products that have already been sold to customers.

Device

PARAGON OXYGENATOR
  • Model / Serial
    Model Catalog: XAMOP***PMP (Lot serial: All Lots); Model Catalog: XAMOPI***MN (Lot serial: All Lots); Model Catalog: XAMOP***PP (Lot serial: All Lots); Model Catalog: XAMOP***MN (Lot serial: All Lots); Model Catalog: XCMOPI140MN (Lot serial: All Lots); Model Catalog: XAMOPI***PMP (Lot serial: All Lots); Model Catalog: XCMOP145PMP (Lot serial: All Lots); Model Catalog: XCMOP43PMP (Lot serial: All Lots); Model Catalog: XAMOPI***PP (Lot serial: All Lots)
  • Product Description
    PARAGON OXYGENATOR;PARAGON INFANT MICRONET INTEGRATED OXYGENATOR;PARAGON INFANT PMP OXYGENATOR;PARAGON NEONATAL PMP OXYGENATOR
  • Manufacturer
    CHALICE MEDICAL LIMITED

Manufacturer

CHALICE MEDICAL LIMITED