Events

Recall of Device Recall Colleague CX Infusion Pump

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
    59448
  • Event Risk Class
    Class 2
  • Event Number
    Z-3007-2011
  • Event Initiated Date
    2011-07-22
  • Event Date Posted
    2011-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102819
  • 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
    The colleague infusion pump may not have met certain air in line (ail) specifications after testing by the baxter global technical service center. this issue could potentially cause a delay in initiation of therapy.
  • Action
    The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump; promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com, and forward this communication to the pump owner as appropriate, if they distributed the pump to another facility or if they are dealers, wholesalers, or distributors/resellers. The letter states "Upon receipt of the returned device, Baxter will perform required testing on the affected COLLEAGUE pump for which you have indicated there is continuing medical necessity. Should Baxter find any issues during testing, Baxter will address those issues through repair or service prior to returning the pump to you at no charge". If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.

Device

Device Recall Colleague CX Infusion Pump
  • Model / Serial
    Product Code: 2M8161, Serial Number 12010746CC
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: MN only.
  • Product Description
    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161. || Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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