Events

Recall of Device Recall Baxter FloGard 6301 Dual Channel 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
    38221
  • Event Risk Class
    Class 1
  • Event Number
    Z-1112-2007
  • Event Initiated Date
    2007-06-21
  • Event Date Posted
    2007-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53176
  • 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 Pumps - Product Code FRN
  • Reason
    Falsified repair/test and inspection records: pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
  • Action
    Baxter telephoned the direct accounts starting on 6/21/07, informing them that functional verification testing may not have been performed on their Flo-Gard and/or Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required functional verification testing. *** Baxter expanded the recall and telephoned the direct accounts starting on 7/30/07, informing them that the electrical safety testing may not have been performed on their Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required electrical safety and all functional verification testing. Follow-up recall letters were sent to the accounts on 8/7/07 reiterating the telephone conversations and providing a list affected pump serial numbers to be removed from service and returned to Baxter for testing. They were also requested to report any malfunction or adverse event related to the Colleague or Flo-Gard Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176. ****Recall 2 Extension******* Baxter expanded the recall for a second time via letter on 8/20/07 and telephone calls starting on 8/21/07, informing the direct accounts that Baxter's investigation found documentation inconsistencies by three more of their service technicians, representing the possibility of incomplete testing and/or documentation by these technicians who serviced Colleague infusion pumps at the account's facility. Without complete and properly do

Device

Device Recall Baxter FloGard 6301 Dual Channel Volumetric Infusion Pumps
  • Model / Serial
    product code 2M8064, serial numbers RA00449, RA00771, RA01093, RA01103FA, RA01143, RA01212FA, RA01241FA, RA01352, RA01392, RA01471FA, 4020417FA, 4110026FA, 4110599FA, 4111648FA, 5010398FA, 5010588FA, 5010892FA, 5030542FA, 5031363FA, 5041317FA, 5041836FA, 5050032FA, 5101954FA, 5111071FA, 5111215FA, 5111217FA, 6020538FA, 6051302FA, 6110083FA, 6110621FA, 6110976FA, 6112818FA, 6113536FA, 6120726FA, 6120952FA, 6121014FA, 6121201FA, 6121249FA, 62004506, 62009976,62013806, 62020266, 62067349, 62069349, 6208698X, 63106801, 63111022, 63111672, 63157766, 63159996, 63173758, 7120494FA, 8020914FA, 8030070FA, 8060094FA, 8080471FA, 8090732FA, 8090762FA, 8111587FA, 8111640FA, 83003592, 83039198, 83044518, 83055250, 83064210, 83069140, 9030584FA, 9030593FA, 9110819FA, 10091327FA, 10091426FA,10091428FA, 10110600FA, 10111225FA, 10111396FA, 10112596FA, 10113463FA, 10113550FA, 10113557FA, 10120142FA, 11030108FA, 11030281FA, 11030908FA, 11031331FA, 11042552FA, 11042740FA, 11042815FA, 11051333FA, 11052654FA, 11052741FA, 11052809FA, 11052957FA, 11061064FA, 11070997FA, 11072099FA, 11081754FA, 11100082FA, 11111119FA, 11120281FA, 11120313FA, 11120327FA, 11120346FA, 12020834FA, 12010409FA, 12031733FA, 12040163FA, 12041054FA, 12060362FB, 12060972FA, 12061359FA, 12061727FA, 12070800FA, 12080863FA, 12090274FA, 12100402FA, 12101819FA, 12102195FA, 12102656FA, 12102742FA, 12102862FA, 12120472FA, 12121033FA, 13010030FA, 13010283FA, 13070260FA, 13070316FA, 13080047FA, 13100967FA, 13101196FA, 13110190FA, 14010668FA, 14050871FA, 14071117FA, 14071128FA, 14071153FA, 14071166FA, 14091581FA, 14091796FA, 14020391FA, 14020002FA, 15013155FA, 15013208FA, 15050126FA, 15050608FA.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming
  • Product Description
    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product code # 2M8064
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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