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...]

      509 Recalls Helmets Due to Risk of Head Injury

      The recalled helmets fail to provide sufficient protection in the event of a crash, posing a risk of head injury. … [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 / Food Recalls / FDA Press Releases / Carefusion Issues Update Regarding Previously Disclosed Recall of the Alaris

Carefusion Issues Update Regarding Previously Disclosed Recall of the Alaris

July 31, 2009 By The FDA Leave a Comment

CareFusion Corporation, which is expected to become a public company following its planned spinoff from Cardinal Health, today issued the following update regarding its previously disclosed recall of the Alaris System:

On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device’s pumping mechanism. This recall also updates the labeling for the Inter Unit Interface (IUI) connectors on the Alaris® System. The potential risks may lead to improper infusion therapy, which could cause serious adverse health consequences or death.

Serial numbers of affected devices, as well as CareFusion’s short term instructions to customers, and the firm’s strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/.

Following the FDA’s 510(k) clearance of the firm’s software correction in July 2009, CareFusion is now implementing corrections for units in the field.

In addition, CareFusion today began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009, Medical Device Recall Notification. The update contains an additional required action to mitigate potential risk before completion of the field corrective action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module. The additional step involves removing the patient-controlled dose request handset from the patient prior to reprogramming the infusion pump.

“Implementation of the corrective action plan is an important area of focus for CareFusion and our customers, to ensure our medical devices in the field are operating as safely and effectively as possible,” said Dwight Winstead, chief operating officer of CareFusion. “We continue to work closely with the FDA under our new quality system with the goal of manufacturing and supporting products that are among the safest in the industry.”

The company recorded an $18 million reserve in its 2009 fiscal third quarter for all actions related to the corrective action plan and continues to believe the amount to be sufficient to fulfill its remediation obligations.

Instructions to customers

Customer inquiries related to this action should be addressed to the CareFusion recall center at 888-562-6018. Additional information about the recall can be found at www.cardinalhealth.com/alaris/medical-device-recall/.

CareFusion will work with customers to minimize disruption while correcting units at their facilities.

In the interim, customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates.

CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company’s web site and set up a dedicated call center for customer support. The FDA has also been apprised of this action.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or at www.fda.gov/medwatch.

About CareFusion Corporation

CareFusion Corporation, a wholly owned subsidiary of Cardinal Health (NYSE:CAH), is expected to become a public company with the planned spinoff of the clinical and medical products businesses of Cardinal Health. The global company serves the health care industry with products and services that help hospitals measurably improve the safety and quality of healthcare. CareFusion develops market-leading technologies including Alaris® IV pumps, Pyxis® automated dispensing and patient identification systems, AVEA and Pulmonetic Systems™ ventilation and respiratory products, ChloraPrep® for infection prevention and MedMined™ services for infection surveillance, neurological monitoring and diagnostic products, V. Mueller® surgical instruments and an extensive line of products that support interventional medicine.

Sold at: See Recall Description

Manufactured in: Food Products – See Recall Description

Remedy: See Recall Description

Consumer Contact:

Other Infomation:

CareFusion employs more than 15,000 people across its global operations. The company has been authorized to have its shares of common stock listed on the New York Stock Exchange under the ticker symbol “CFN.” More information may be found at carefusion.com.

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: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

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

509 Recalls Helmets Due to Risk of Head Injury

July 2, 2025 By The CPSC

SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi

July 2, 2025 By The CPSC

Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard

July 2, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop

July 2, 2025 By The CPSC

Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard

July 2, 2025 By The CPSC

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

iHerb Recalls Bottles and Blister Packs of California Gold Nutrition Iron Supplements Due to Risk of Serious Injury or Death from Child Poisoning; Violation of Federal Standard for Child Resistant Packaging

June 25, 2025 By The CPSC

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

  • 509 Recalls Helmets Due to Risk of Head Injury
  • SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi
  • Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard
  • DEWALT Recalls Grinder Flap Discs Due to Laceration and Injury Hazards
  • Trane Recalls Gas/Electric Packaged Units Due to Risk of Gas Leak, Fire Hazard
  • Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop
  • Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
-- 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