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
    56084
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-26
  • 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 corporation is recalling one (1) sigma spectrum infusion pump with master drug library that was shipped with a component that does not meet standards for withstanding an electrostatic discharge in excess of 15 kilovolts. such exposure could cause the pump to stop unexpectedly with no audible alarm or visual display of the alarm status.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Model / Serial
    Model Catalog: 35700 (Lot serial: 997333)
  • Product Description
    SPECTRUM INFUSION PUMP W/ MASTER DRUG
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION