Events

Recall of OUTLOOK SAFETY INFUSION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by B. BRAUN MEDICAL INC..

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
    26989
  • Event Risk Class
    II
  • Event Initiated Date
    2005-08-10
  • 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
    Potential for an unintended infusion rate when the outlook pump is used in dose mode in a manner that is inconsistent with the instructions in the operating manual.

Device

OUTLOOK SAFETY INFUSION SYSTEM
  • Model / Serial
    Model Catalog: 620-100 (Lot serial: software version 151431); Model Catalog: 620-100 (Lot serial: software version 151441); Model Catalog: 620-100 (Lot serial: software version 151423); Model Catalog: 620-100 (Lot serial: software version 151447)
  • Product Description
    Outlook Safety Infusion System
  • Manufacturer
    B. BRAUN MEDICAL INC.

Manufacturer

B. BRAUN MEDICAL INC.