Events

Recall of SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

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
    34958
  • Event Risk Class
    I
  • Event Initiated Date
    2014-09-08
  • 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
    Baxter has identified a limited number (2) of sigma spectrum infusion pumps with master drug library product code 35700bax that may not have been correctly serviced according to established procedures by one service technician during the time period of may 5 2014 through june 3 2014. while these pumps passed testing requirements following service baxter cannot be assured that each device is free of workmanship defects that may impact pump performance and safety.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

Manufacturer

BAXTER CORPORATION