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
    26996
  • Event Risk Class
    III
  • Event Initiated Date
    2012-06-05
  • 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
    Sigma has become aware of an unintended use of the example drug library. some customers have used the example drug library to create their own facility drug library for use on patients or transmitted to a pump. sigma provided the example drug library solely as an example of how user can apply the functions of a drug library to ensure safe and effective pump use.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Model / Serial
    Model Catalog: 35700 (Lot serial: MDL Editor Software v6.2.4)
  • Product Description
    SIGMA SPECTRUM MDL EDITOR SOFTWARE
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION