Events

Recall of GEMSTAR INFUSION SUITE

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
    Recall
  • Event ID
    23296
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-31
  • 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.
    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.

Device

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

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC