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
    59270
  • Event Risk Class
    Class 2
  • Event Number
    Z-2853-2011
  • Event Initiated Date
    2011-07-05
  • Event Date Posted
    2011-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102087
  • 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
    While replacing a defective pump head mechanism and performing calibration, baxter's service center may have failed to apply glyptol (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.
  • Action
    Baxter Healthcare Corporation telephoned its customers on July 1, 2011 and sent a follow up "URGENT PRODUCT RECALL" letter dated July 6, 2011, informing them that the Glyptol (a red insulating varnish) may not have been applied on the Air-In-Line (AIL) circuit board. The letter described the product, problem and actions to be taken. The customers were instructed to locate the affected pumps, remove from service and return to Baxter for inspection as soon as possible. If GLYPTOL is found to be missing, recalibration will be performed and GLYPTOL will be applied per requirement before returning the pumps back to the customer at no cost. The customer was instructed to complete and sign the attached customer reply form. The letter states that if the COLLEAGUE Pumps were distributed to other facilities, please forward communication to the pump owner as appropriate. For any questions contact The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time, Monday through Friday.

Device

Device Recall Colleague CX Infusion Pump
  • Model / Serial
    Product Code: 2M8161, Lot Numbers 13060235CC and 13090748CC
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution -- including the state of Pennsylvania.
  • Product Description
    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. || Product Usage: 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