Events

Recall of B. Braun Outlook Safety Infusion System Burette Set

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
    65993
  • Event Risk Class
    Class 2
  • Event Number
    Z-2166-2013
  • Event Initiated Date
    2013-08-05
  • Event Date Posted
    2013-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121164
  • 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
    Pump, infusion - Product Code FRN
  • Reason
    Reports were received of an incorrectly assembled outlook safety infusion system burette set (product code 375038), and the investigation determined that one of the ultrasite injection sites and corresponding low pressure backcheck valve was assembled upside down.
  • Action
    On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form.

Device

B. Braun Outlook Safety Infusion System Burette Set
  • Model / Serial
    Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL, NY, NJ, and TX.
  • Product Description
    Outlook Safety Infusion System Burette Set. || For intravenous fluid administration.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Manufacturer Address
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA