The U.S. Food and Drug Administration on Wednesday gave Minnesota-made syringe infusion pumps a Class 1 recall classification, the most serious category of market withdrawals.
FDA slaps Class 1 recall label on Minnesota-made syringe infusion pump
The regulatory action affects more than 118,000 devices used in neonatal and pediatric patients, as well as adults in ICUs. The infusion pumps are made in Oakdale.
July 20, 2022 at 8:45PM
The device is made by Smiths Medical, which was based in Plymouth until it was acquired by a California firm in January. Eight software malfunctions were found with specific lot numbers of its Medfusion 3500 and 4000 infusion pumps.
These software problems led to seven serious injuries and one known death, according to the company.
Syringe pumps deliver precise amounts of blood, drugs, antibiotics and other therapeutic fluids through infusion tubing. According to the FDA recall notice, they are mostly used in neonatal and pediatric patients or operating rooms and intensive care units for adults.
Smiths Medical first issued a 15-page Urgent Medical Device Correction letter in April detailing the problems, including false alarms going off and abnormal circuit board behavior that could cause an internal clock system failure.
The recall affects more than 118,000 devices distributed over a 17-year time span, between October 2004 and Feb. 17, 2022.
"We intend to address the issues described in the recall notice through upcoming software releases. We will update affected pumps that are within their service life at no charge and are in the process of contacting customers to schedule the implementation of the software updates when the updates are released," said Tom McCall, a spokesman for ICU Medical Inc., which acquired Smiths Medical in January.
San Clemente, Calif.-based ICU Medical Inc. acquired Smiths Medical in a $2.5 billion cash and stock deal. The company was previously owned by the London-based Smiths Group.
An ICU representative said Plymouth is no longer considered its headquarters since the Smiths Medical name will ultimately disappear. ICU is in the process of integrating and rebranding the company under its name and leadership.
The company currently has 495 employees in the Twin Cities. The infusion pumps are manufactured in Oakdale.
The complaint marks the second time since 2022 that DOJ has challenged deals in the Minnetonka-based company’s Optum division for health care services.
