Events

Recall of Device Recall FloGard 6301 Dual Chamber Volumetric Infusion Pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

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
    36872
  • Event Risk Class
    Class 2
  • Event Number
    Z-0633-2007
  • Event Initiated Date
    2006-11-27
  • Event Date Posted
    2007-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49482
  • 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
    There is the potential for non-detection of, and no alarm for, upstream occlusion for flo-gard volumetric infusion pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, buretrol or blood filter.
  • Action
    Baxter sent the 11/27/06 Urgent Device Correction letter to all Flo-Gard Volumetric Infusion Pump customers, to the attention of the Vice President of Nursing and the Biomedical Engineer, via first class mail to alert them to the potential for non-detection of, and no alarm for, upstream occlusion under specific conditions for Flo-Gard Volumetric Infusion Pumps if the occlusion occurs above a flexible chamber (such as a drip chamber, Buretrol or blood filter), and to provide the addendum to the operator manual to address these specific conditions. The letters included the mitigations and risks associated with each of the conditions that could potentially cause this situation. This information was included in the letter, as well as the Operator''s Manual Addendum, which Baxter requested to attach a copy to all Flo-Gard Operator''s Manuals in their facility. Baxter instructed the customers to share this information with all staff members, services and facilities that use Flo-Gard pumps. Any questions were directed to Baxter''s Global Technical Services at 1-800-843-7867, prompt 2. Although Baxter previously notified customers on 3/5/99 that they would no longer support or service the Flo-Gard 6200 and 6300 devices as of 12/1/99, these product codes were included in this letter due to a similar potential for this issue. Should the customer still have these 6200 or 6300 devices in their possession, Baxter recommended that they be taken out of service due to obsolescence of the appropriate components. The accounts were requested complete the enclosed reply form acknowledging receipt of the letter and dissemination of the information to their staff.

Device

Device Recall FloGard 6301 Dual Chamber Volumetric Infusion Pumps
  • Model / Serial
    all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA, Puerto Rico, Argentina, Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Honduras, India, Indonesia, Ireland, Italy, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Singapore, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.
  • Product Description
    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA