Events

Recall of Device Recall Outlook ES Safety Infusion System

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
    59847
  • Event Risk Class
    Class 2
  • Event Number
    Z-0007-2012
  • Event Initiated Date
    2010-07-20
  • Event Date Posted
    2011-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103856
  • 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
    The outlook es dose guard care area can inadvertently be exited when the pump enters the kvo (keep vein open) state. the same condition can occur when a sequence of hold-hold key strokes are performed on the pump key panel.
  • Action
    The firm, B. Braun Medical Inc., sent an "URGENT: FIELD CORRECTION" letter dated September 8, 2011 to its customers. The letter described the product, problem and actions to be taken. The firm informed the customers that a B. Braun representative will be contact ing them to schedule a field software upgrade of the affected pumps. The customers were instructed to complete and return the FIELD CORRECTION INFORMATION FORM via mail using the enclosed envelop and contact B. Braun Customer Service for shipping instructions at 1-800-627-7867 if product is to be returned. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Technical Product Support at 1-800-627-7867 (800-627-PUMP).

Device

Device Recall Outlook ES Safety Infusion System
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.
  • Product Description
    Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES || B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 || The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.
  • 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