According to a news release published on startribune.com, the U.S. Food and Drug Administration has issued a Class I recall of certain lots of Smiths Medical Medfusion 3500 and 4000 Infusion Pumps. The recalled Minnesota-made syringe infusion pumps are used in pediatric and neonatal patients and adults in Intensive Care Units. This recall will affect over 118,000 medical devices. The U.S. Food and Drug Administration stated that the Class 1 recall classification is the most severe type of market withdrawal.
The medical devices are made by Smiths Medical, which was acquired by a California firm back in January. Eight Medfusion 3500 and 4000 infusion pump software malfunctions were discovered concerning certain infusion pump lot numbers. The report states that the software issues have caused one fatality and seven serious injury incidents, according to Smiths Medical.
These types of syringe pumps supply precise amounts of medications, blood, antibiotics, and other medicinal fluids via infusion tubing. According to this FDA recall announcement, these infusion pump medical devices are typically used in pediatric and neonatal patients or in operating rooms and adult intensive care units.
In April, Smiths Medical published a 15-page Urgent Medical Device Correction letter that detailed the issues, including a warning of false alarms going off and unusual circuit board behaviors that might lead to internal clock system failures. The recall involves 118,000 devices that were distributed throughout a 17-year time period ranging from October 2004 until February 17, 2022.
Tom McCall, a spokesman for ICU Medical Inc., stated that the company intends to manage the issues as described in the FDA’s recall notice via upcoming software releases. The company will update recalled pumps that are inside of their service life at no cost, and the company is in the process of notifying its customers to arrange an installation of the software updates as soon as those updates are released. ICU Medical Inc. acquired Smiths Medical back in a $2.5 billion cash and stock deal. The Smiths Group previously owned Smiths Medical.
An ICU Medical Inc representative stated that the Smiths Medical name would eventually disappear. ICU Medical Inc is currently in the process of rebranding the company under the ICU Medical Inc name and leadership. ICU Medical Inc is based in Minnesota and has 495 employees. The recalled infusion pumps were manufactured in Oakdale.
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