US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Areson Recalls Rolanstar 6-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Multiple Violations of Federal Regulations for Clothing Storage Units; Sold Exclusively on Amazon.com

      The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Drug Recalls / Urgent Recall of Baxter Healthcare COLLEAGUE Triple Channel Volumetric Infusion Pumps

Urgent Recall of Baxter Healthcare COLLEAGUE Triple Channel Volumetric Infusion Pumps

July 22, 2007 By E. Sizemore Leave a Comment

UPDATE: On August 7, 2007, Baxter Healthcare Corporation announced an update to the July 25, 2007 Class I recall press release regarding falsified repair, test and inspection data sheets, which included electrical safety data for COLLEAGUE and FLO-GARD infusion pumps. Baxter has expanded the recall to include an additional 986 COLLEAGUE infusion pumps, which need to be returned to the company for repeat inspection, because of falsified electrical safety data. Read more on the FDA press release.

UPDATE: On June 21, 2007, Baxter contacted their customers informing them that some repair, test and inspection data sheets, including electrical safety data, were falsified. As a result, it may be possible that pumps sent to be serviced, repaired, or corrected were returned without service being performed on them. This may result in over infusion, under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can result in death!

Baxter Healthcare and the US Food and Drug Administration (FDA) notified healthcare professionals and consumers Friday of a Class I Recall (the most serious) of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.

Doctors, nurses, caregivers and other medical professionals are advised to remove all the recalled triple channel Baxter pumps from service immediately.

Infusion pumps deliver controlled amounts of medications and other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct lines into the bloodstream.

The Baxter infusion pumps were recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. The error occurs during user programming with all three channels infusing fluids at the same time.

There are multiple reports of serious injuries that are associated with this medical device defect. In reported cases, the Baxter infusion pump stopped infusing which caused it to activate an audible and a visual alarm. Interruption of life-sustaining therapy could lead to serious injury or death.

Again, doctors, nurses, caregivers and other medical professionals are advised to remove all the affected triple channel pumps from service immediately. Patients and COLLEAGUE customers with questions should contact Baxter Medical Delivery Services at 1-800-843-7867.

Baxter Healthcare Corp.
Rt. 120 & Wilson Rd.
Round Lake, Illinois 60073

NOTES:

This is not the first time Baxter Healthcare has had to initiate a Class I Recall of COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps. See these recalls from 2005.

From June 20, 2007 through June 21, 2007, Baxter telephoned their customers and informed them that Baxter had received multiple reports of newly upgraded COLLEAGUE Triple Channel Infusion Pumps alarming, displaying an error code and stopping infusion.

These reported events occurred during user programming with all three channels infusing fluids at the same time. In all cases, the pump stopped the infusions in all three channels, which caused it to activate an audible and visual alarm.

Baxter requested that all of the affected triple channel pumps be immediately removed from service. These pumps were identified by two attached hangtags entitled “Battery and Power On.”

Baxter informed their customers that representatives would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps.

COLLEAGUE® customers with questions may contact Baxter Healthcare’s Medical Delivery Services at 1-800-843-7867.

For more information about this medical device recall, please see the Baxter’s press release.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of the Baxter Healthcare COLLEAGUE Triple Channel Volumetric Infusion Pumps or any other medical device or pharmaceutical drug to the FDA’s MedWatch Adverse Event Reporting program below.

Report Online: www.fda.gov/MedWatch/report.htm

Report by Regular Mail: use postage-paid FDA form 3500.
Mail to:
MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787

Or FAX to: 1-800-FDA-0178

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: Drug Recalls

About E. Sizemore

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Areson Recalls Rolanstar 6-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Multiple Violations of Federal Regulations for Clothing Storage Units; Sold Exclusively on Amazon.com

May 21, 2025 By The CPSC

Primark Recalls DTR Plush Bag Stitch and DTR Plush Bag Angel Due to Choking and Ingestion Hazards

May 21, 2025 By The CPSC

Nezmdi Infant Swings Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Multiple Federal Safety Violations; Sold Exclusively on Amazon.com by Nezmdi

May 21, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

PennRose Farms Issues Recall of Whole Cucumbers Because Of Possible Health Risk

May 21, 2025 By The FDA

New Grains Gluten Free Bakery Issues Allergy Alert on Undeclared Eggs, Tree Nuts, Soy, and Milk in Bakery Products

May 21, 2025 By The FDA

Bedner Growers, Inc. Recalls Cucumbers Because of Possible Health Risk

May 19, 2025 By The FDA

R&M Trading LLC Issues Allergy Alert on Undeclared Milk in R&M Refresher Instant Milk Tea Powder

May 17, 2025 By The FDA

South Asian Food Inc. Issues Allergy Alert on Undeclared Peanuts in “Bengal King Family Pack Vegetable Singara”

May 16, 2025 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

R&M Trading LLC Issues Allergy Alert on Undeclared Milk in R&M Refresher Instant Milk Tea Powder

May 17, 2025 By The FDA

South Asian Food Inc. Issues Allergy Alert on Undeclared Peanuts in “Bengal King Family Pack Vegetable Singara”

May 16, 2025 By The FDA

Element 112, LLC dba Madeline’s Pâtisserie Issues Allergy Alert on Undeclared Wheat in Croissants and Croissant Buns

May 14, 2025 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Areson Recalls Rolanstar 6-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Multiple Violations of Federal Regulations for Clothing Storage Units; Sold Exclusively on Amazon.com
  • Primark Recalls DTR Plush Bag Stitch and DTR Plush Bag Angel Due to Choking and Ingestion Hazards
  • Nezmdi Infant Swings Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Multiple Federal Safety Violations; Sold Exclusively on Amazon.com by Nezmdi
  • Macy’s Recalls Holiday Lane Infant Footed Pajamas Due to Injury Hazard; Sold Exclusively by Macy’s
  • Sivan Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Multiple Violations of Federal Regulations for Clothing Storage Units; Sold on Wayfair.com by Anji Guyou Furniture
  • PennRose Farms Issues Recall of Whole Cucumbers Because Of Possible Health Risk
  • New Grains Gluten Free Bakery Issues Allergy Alert on Undeclared Eggs, Tree Nuts, Soy, and Milk in Bakery Products
  • Bedner Growers, Inc. Recalls Cucumbers Because of Possible Health Risk
  • R&M Trading LLC Issues Allergy Alert on Undeclared Milk in R&M Refresher Instant Milk Tea Powder
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in