According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA HEALTHCARE 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
  • Event ID
  • Event Risk Class
  • Event Initiated Date
  • Event Country
  • Event Source
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    Gemstar devices utilizing the pc application are capable of being programmed for a bolus lower lockout limit interval less than the programmed hard limit value stored in the gemstar sp infusion suite database pc application. this could potentially result in the infuser granting more frequent bolus delivery requests than intended in programming the hard limit potentially causing over-delivery of medication to the patient.


  • Model / Serial
    Model Catalog: 13092 (Lot serial: 84832G1); Model Catalog: 13092 (Lot serial: 72613G1)
  • Product Description
    GemStar SP Infusion Suite Database PC
  • Manufacturer


  • Manufacturer Address
  • Manufacturer Parent Company (2017)
  • Source