Events

Recall of OUTLOOK ES 100

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
    125939
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-07
  • 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
    The outlook es dose guard care area can inadvertently be exited when the pump enters the kvo (keep vein open) state when a sequence of hold-hold key strokes are performed on the pump key panel.

Device

OUTLOOK ES 100
  • Model / Serial
    Model Catalog: 621-100ES (Lot serial: >10 SERIAL NUMBERS CONT. MFR)
  • Product Description
    OUTLOOK 621-ES100
  • Manufacturer
    B. BRAUN MEDICAL INC.

Manufacturer

B. BRAUN MEDICAL INC.