Events

Recall of Horizon Pump Metriset 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
    37856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0819-2007
  • Event Initiated Date
    2007-04-18
  • Event Date Posted
    2007-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51962
  • 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
    IV Set - Product Code FPA
  • Reason
    Secondary infusion backs up into primary container.
  • Action
    The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.

Device

Horizon Pump Metriset Burette Set
  • Model / Serial
    Lot numbers: 60888186 exp 9/11 and 60869008 exp 6/11
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets.
  • 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