Events

Recall of ALARIS SYSTEM - PCA MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA 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
    26782
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-23
  • 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
    The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. it is important to note that the syringe plunger gripper can be manually closed by the user. if the user follows the alaris system user manual and ensures the syringe plunger gripper is closed there is no risk of harm to the patient. if however the gripper is not closed around the syringe there is a negligible risk of siphoning.

Device

ALARIS SYSTEM - PCA MODULE
  • Model / Serial
    Model Catalog: 8120 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8110 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ALARIS PCA MODULE MODEL 8120;ALARIS SYRINGE MODULE MODEL 8110
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.