Events

Recall of Colleague Mono, CX and CXE 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
    56425
  • Event Risk Class
    Class 1
  • Event Number
    Z-0001-2011
  • Event Initiated Date
    2010-08-04
  • Event Date Posted
    2010-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93646
  • 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
    The fda sent a letter to baxter on april 30, 2010, ordering the company to recall and destroy all models of its colleague volumetric infusion pumps currently in use in the united states. fda determined that this action is necessary, as baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the colleague pumps still in use. this recall is a consolidation of al.
  • Action
    Baxter Healthcare Corporation sent "Urgent Product Recall" letters dated August 4, 2010 to all Colleague Infusion Pump customers in the U.S., to the attention of the Hospital Administrator, Chief Executive Officer, Chief Operating Officer, Chief Medical Officer and Chief Nursing Officer, referencing Baxter's May 3, 2010 announcement to recall all Colleague pumps from the U.S. market pursuant to an order under its existing consent decree with the FDA. The letters provided the customers with important information regarding the actions they must take prior to November 14, 2010 in order to continue using their Colleague pumps during the transition period. Customers were instructed to complete the attached Certificate of Medical Necessity Form and return it to Baxter as soon as possible, but no later than November 14, 2010, by scanning and e-mailing to Baxter at FCA@Baxter.com. Any questions were directed to their local Baxter Sales Representative or by calling the Center for One Baxter 1-800-422-9837, between 8AM and 5 PM Central Standard Time (CST). *** On July 20, 2011 Baxter sent recall letters to those Colleague customers who had not completed a decision form regarding the status and replacement of their Colleague Pumps. The accounts were asked to inform their Baxter sales representative as soon as possible of their pump decision, and to complete the attached customer reply form and return it to Baxter via fax or scanned e-mail. ***

Device

Colleague Mono, CX and CXE Volumetric Infusion Pumps
  • Model / Serial
    All product numbers and all serial numbers sold in the U.S.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico
  • Product Description
    Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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