Events

Recall of SIGMA 8002 PLUS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER 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
    31563
  • Event Risk Class
    II
  • Event Initiated Date
    2007-09-28
  • 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 8000/8002 infusion pumps are not compatible with the recently redesigned hospira cair roller clamp. customers should not use the redesigned roller clamp with the sigma 8000/8002 infusion pumps.

Device

SIGMA 8002 PLUS
  • Model / Serial
    Model Catalog: 35061 (Lot serial: ALL LOTS); Model Catalog: 35001 (Lot serial: ALL LOTS)
  • Product Description
    SIGMA 8002 INFUSION PUMP
  • Manufacturer
    BAXTER HEALTHCARE CORPORATION

Manufacturer

BAXTER HEALTHCARE CORPORATION
  • Manufacturer Address
    MEDINA
  • Source
    HC