Events

Recall of Device Recall Baxter 6060 MultiTherapy 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
    28037
  • Event Risk Class
    Class 2
  • Event Number
    Z-0376-04
  • Event Initiated Date
    2003-12-17
  • Event Date Posted
    2004-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31080
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code FRN--
  • Reason
    Premature motor failure.
  • Action
    Baxter sent letters dated 12/17/03 to all Baxter 6060 Multi-Therapy Infusion Pump accounts that received pumps manufactured with the affected motors or who had their pumps refurbished with affected motors. The letters included a list of affected pump serial numbers for each facility. The accounts were informed of the possible premature motor failure, and were requested to contact Baxter via fax to schedule a service call to correct the pumps.

Device

Device Recall Baxter 6060 MultiTherapy Infusion Pump
  • Model / Serial
    serial numbers 108050HR, 108183HR, 108298HR, 109036HR, 109216HR, 109622HR, 110004HR, 110700HR, 111126HR, 111270HR, 111540HR, 112441HR, 201178HR, 308361HR/308440HR, 309001HJ/309030HJ, 309001HR/309345HR 309001HW/309015HW, 310001HG/310010HG , 310001HW/310010HW , 310007HR/310088HR, and HR1976/HR27480. Only those pumps within these serial numbers with installed motor assemblies from date codes 33/03, 34/03 and 35/03 are affected.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide, and internationally to Sweden, Germany, the United Kingdom, Australia and Japan.
  • Product Description
    Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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