Events

Recall of Device Recall Colleague CX Volumetric 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
    57515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0931-2011
  • Event Initiated Date
    2010-12-01
  • Event Date Posted
    2011-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96445
  • 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 the infusion pump was being serviced at the baxter service center, it was inadvertently routed to the packaging area before the final inspection.
  • Action
    Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (800) 437-5176.

Device

Device Recall Colleague CX Volumetric Infusion Pump
  • Model / Serial
    Product Code: 2M8161, serial number 15030799CC
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Texas
  • Product Description
    Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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