Events

Recall of ALARIS PATIENT CARE SYSTEM- PCA MODULE

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

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
    59357
  • Event Risk Class
    I
  • Event Initiated Date
    2009-03-19
  • 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
    Potential risk when the alaris pca module is used with the alaris pc unit. the alaris pca module can potentially infuse above or below the intended infusion dose for a specific sequence of events syringe volume warning message occlusion warning messagedfu for fluid ingress and dfu for iui connectors.

Device

ALARIS PATIENT CARE SYSTEM- PCA MODULE
  • Model / Serial
    Model Catalog: 8120 (Lot serial: ); Model Catalog: 8015 (Lot serial: INFORMATION.); Model Catalog: 8015 (Lot serial: A TOTAL OF 4068 SERIAL); Model Catalog: 8015 (Lot serial: NUMBERS-SEE MANUFACTURERS)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    ALARIS PCA MODULE
  • Manufacturer
    CARDINAL HEALTH CANADA

Manufacturer

CARDINAL HEALTH CANADA
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC