Events

Recall of Device Recall B. Braun Outlook

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    57099
  • Event Risk Class
    Class 1
  • Event Number
    Z-0837-2011
  • Event Initiated Date
    2010-08-24
  • Event Date Posted
    2011-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95391
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Infusion pump - Product Code FRN
  • Reason
    Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. under certain conditions in a network environment, management processor may become non-responsive, ceasing normal operation.
  • Action
    B. Braun Medical Inc. notified consignee by letter on August 24, 2010.

Device

Device Recall B. Braun Outlook
  • Model / Serial
    Model No. 621-400ES. Premarket Notifications K011975 and K994375. Device Listings D051037 and D051592.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Virginia and New York
  • Product Description
    Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets
  • Manufacturer
    B Braun Medical, Inc

Manufacturer

B Braun Medical, Inc
  • Manufacturer Address
    B Braun Medical, Inc, 1601 Wallace Dr Ste 150, Carrollton TX 75006-6690
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA