Events

Recall of ALARIS SYSTEM - PUMP

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
    24163
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-09
  • 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 user can reproduce a free-flow condition if the clinician does not close the roller clamp on the iv administration set prior to opening the pump door and the pump door is opened by using a "flick" of the door latch that causes the door to "pop" open instead of opening the door by slowly raising the latch. this flicking motion may cause the centered sear design to not effectively engage with the safety clamp fitment which can cause unintended flow possibly resulting in an over infusion to the patient.

Device

ALARIS SYSTEM - PUMP
  • Model / Serial
    Model Catalog: 8100LVP (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ALARIS SYSTEM MODEL 8100LVP
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.