Recall of VENTILATOR ACCESSORIES MASK ADAPTER

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

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
    22355
  • Event Risk Class
    I
  • Event Initiated Date
    1998-07-29
  • Event Country
  • 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
    Some units have a thin clear membrane located within the center of the product which may interfere with and/or block the airflow to the patient.

Device

  • Model / Serial
    Model Catalog: P001820 (Lot serial: Y8D0452 Y8D0453 Y8E0943); Model Catalog: P001820 (Lot serial: Y8B0428 Y8C1917 Y8C1918); Model Catalog: P001820 (Lot serial: Y8A0338 Y8A0339 Y8B0427); Model Catalog: P001820 (Lot serial: Y7P0394 Y7P0395 Y7S0121); Model Catalog: P001820 (Lot serial: Y7L0963 Y7N0280 Y7N0281); Model Catalog: P001820 (Lot serial: Y7K0778 Y7K0779 Y7L0962); Model Catalog: P001820 (Lot serial: Y7H0170 Y7J1131 Y7J1132)
  • Product Description
    VENTILATION ACCESSORIES MASK ADAPTER
  • Manufacturer

Manufacturer