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
    64150
  • Event Risk Class
    Class 2
  • Event Number
    Z-2175-2013
  • Event Initiated Date
    2012-12-05
  • Event Date Posted
    2013-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115430
  • 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
    B. braun medical inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the outlook pump models 620-100 and 620-200. this could have occurred after periods of lost dc (battery) power or out of tolerance low power. this could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on.
  • Action
    The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).

Device

Device Recall Outlook ES Safety Infusion System
  • Model / Serial
    Models 620-100 and 620-200; multiple serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Disribution: USA (nationwide) and country of: Canada.
  • Product Description
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the 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