FDA Recall Instituted after Company Fails to Redirect URL Injuries

UPDATED: Jul 13, 2023Fact Checked

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Jeffrey Johnson

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 13, 2023

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UPDATED: Jul 13, 2023Fact Checked

The U.S. Food & Drug Administration (FDA) has ordered Baxter Healthcare to recall and destroy all of its Colleague Volumetric Infusion Pumps, reimburse customers for the value of the recalled devices and assist customers in finding replacements. The recall was ordered after the medical device giant failed to address Colleague Pump 56,000 injuries and 500 deaths reported by patients and their families for years.

Colleague Volumetric Infusion Pump recall

The FDA ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps – which are used to deliver fluids into a patients body in a controlled manner. According to the FDA, the pumps are widely used in hospitals, clinical settings and for in-home use because they are supposed to allow for a greater level of accuracy in fluid delivery.

However, the FDA said that there have been longstanding issues with Baxter’s infusion pumps which it said are defectively designed, have software defects, user interface problems and are subject to mechanical and electrical failures. While the FDA has been working with Michigan-based Baxter Healthcare since 1999 to correct these issues, the company never stepped up to the plate.

Suffered harm from a Baxter Infusion Pump? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights. [Sponsored link]

The FDA obtained a consent decree of permanent injunction in 2006 in which Baxter finally agreed to stop manufacturing and distributing all models of the Colleague pump until it corrected manufacturing deficiencies and brought the devices into FDA compliance. The company did not comply and the FDA issued a Class I recallin April 2010. Baxter was given one more chance to fix the problems. It’s solution was a letter to the FDA stating that it just couldn’t address the issues right now.

Permanent injunction issued

Baxter’s plan was to wait until 2012 to address these issues. That was unacceptable to the FDA which finally put its enforcement foot down, obtained a permanent injunction and forced the company to:

  • Recall all of its Colleague Infusion Pumps – of which there are thought to be 200,000 in circulation
  • Destroy the pumps once returned
  • Reimburse customers for the value of the recalled device
  • Assist in finding a replacement for these customers at no cost

Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

500 deaths / 56,000 serious injuries

FDA & Drug Litigation attorneys say that the company put profits over patient safety and point to FDA statements that the Administration has received more than 500 reports of death and 56,000 reports of serious injuries. If you’ve been injured by a defective Baxter Colleague Volumetric Infusion Pump, contact an experienced products liability lawyer in your state right away.

Suffered harm from a Baxter Infusion Pump? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights. [Sponsored link]

Case Studies: Insurance Implications of FDA Recall Due to URL Redirect Failures

Case Study 1: Product Liability Insurance for Medical Device Manufacturers

In the case of the FDA recall initiated after a company fails to redirect URL injuries, product liability insurance becomes crucial for the medical device manufacturer involved. Product liability insurance provides coverage for claims or lawsuits alleging harm caused by defective products.

In this scenario, the manufacturer failed to address reported injuries and deaths associated with its medical device, leading to the FDA recall. Product liability insurance would help protect the company by covering legal defense costs, settlements, or judgments related to the recall and any resulting claims, ensuring financial stability and safeguarding the company’s reputation.

Case Study 2: Errors and Omissions Insurance for Web Developers

The failure to redirect the URL in this case study may involve the responsibility of web developers or IT professionals who were tasked with managing the company’s online presence. Errors and omissions insurance, also known as professional liability insurance, provides coverage for claims arising from professional negligence, errors, or omissions.

In this scenario, if the failure to redirect the URL is deemed as a mistake or oversight by the web developers, errors and omissions insurance would cover legal defense costs and potential damages associated with claims filed against them, protecting their financial interests and professional reputation.

Case Study 3: Cyber Insurance for Data Breach and Liability

In situations where the URL redirection failure involves the potential exposure of sensitive customer data or a data breach, cyber insurance becomes relevant. Cyber insurance provides coverage for the financial losses, liabilities, and legal costs associated with data breaches, cyberattacks, or privacy breaches.

If the URL redirection issue resulted in unauthorized access to customer data or other cyber incidents, cyber insurance would help mitigate the financial impact by covering expenses such as forensic investigations, notification and credit monitoring for affected individuals, legal defense, and potential liability claims.

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Jeffrey Johnson

Insurance Lawyer

Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

Insurance Lawyer

Mary Martin

Published Legal Expert

Mary Martin has been a legal writer and editor for over 20 years, responsible for ensuring that content is straightforward, correct, and helpful for the consumer. In addition, she worked on writing monthly newsletter columns for media, lawyers, and consumers. Ms. Martin also has experience with internal staff and HR operations. Mary was employed for almost 30 years by the nationwide legal publi...

Published Legal Expert

Editorial Guidelines: We are a free online resource for anyone interested in learning more about legal topics and insurance. Our goal is to be an objective, third-party resource for everything legal and insurance related. We update our site regularly, and all content is reviewed by experts.

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