Recall of Device Recall Baxter Single Day INFUSOR System

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 MEB
  • Reason
    Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.
  • Action
    Baxter on 11/30/07 sent an Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential leaks during filling or use of the infusor. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any clinical/technical questions were directed to the Baxter Healthcare Product Information Center at 1-800-933-0303.


  • Model / Serial
    Lot Numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043, 07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074, 07J016, 07J018, 07J052, 07J054, and 07K020
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide: USA, Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Portugal, San Marino, Spain, Sweden, United Kingdom, South Africa, Colombia, Argentina, Hong Kong, Australia and New Zealand.
  • Product Description
    Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer


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