FDA Recall of Medfusion Pumps

Dec 28,2019

Last week, the Food and Drug Administration announced that they were declaring a “Class 1” recall of nearly 600 4000-series drug-infusion pumps designed for pediatric use by Smiths Medical. According to current labeling conventions, a Class 1 recall implies that the defects apparent in the product could lead to injury or, in worst case scenarios, death.

The story of this particular recall begins in October, when Smiths Medical notified customers about a software problem prevalent in 626 devices that had been sourced to Colorado, Maryland and the state of New York. The software problem that had been identified primarily affected the low battery warning system found inside of the pump. According to Smiths Medical, this particular issue could result in a complete failure of the low battery warning system. Given the fact that these pumps are designed to provide a continuous stream of medications into an IV line, a battery failure could be catastrophic for patients.

Taking the Right Precautions

Individuals who are currently using a Medfusion 4000 syringe pump should check to determine which firmware version their product is currently using. This can be checked by simply powering on the device and seeing what version number is displayed on the launch screen. If the pump is using firmware Version 1.7.0, owners should immediately complete the notice recall form which has been sent to them by Smiths Medical. After Smiths Medical receives the form, they will then send a shipping label to the customer in order to facilitate the return of the recalled product. A copy of the complete response form must be included with the product.

Drug Injury Attorneys in Cathedral City

Our firm has been personal injury cases throughout the California Low Desert and High Desert communities for over 30 years. With a 95% success rate, the California personal injury attorneys at Walter Clark Legal Group will fight to hold those responsible for your loss accountable and win compensation to cover medical bills, lost wages, and pain and suffering. If you have been injured in an accident and want to discuss your legal options, contact us today for a free consultation with an experienced personal injury lawyer. We have offices in Indio, Rancho Mirage, Victorville, and Yucca Valley and represent clients through the entire California Low Desert and High Desert communities.

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DISCLAIMER: The Walter Clark Legal Group blog is intended for general information purposes only and is not intended as legal or medical advice. References to laws are based on general legal practices and vary by location. Information reported comes from secondary news sources. We do handle these types of cases, but whether or not the individuals and/or loved ones involved in these accidents choose to be represented by a law firm is a personal choice we respect. Should you find any of the information incorrect, we welcome you to contact us with corrections.