The FDA this week said it’s designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency’s most serious level of medical device recall.
The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, 2023.
The Medfusion syringe infusion pump is meant to precisely administer blood, lipids, drugs, antibiotics, and therapeutic fluids. Fluid delivery can be arterial, epidural, intravenous, intrathecal, subcutaneous, or enteral.
ICU Medical’s Smiths Medical ASD reports problems with earlier software versions of the medical pump. The software issues may affect the pump’s alarm system, the pump, the control screen, and other parts of the pump. According to the FDA, undetected software-related issues could cause device failure, delay or interruption of therapy, or failure to deliver therapy per the programmed setting.
The FDA said there has been one reported injury and no deaths related to the software problem.
Smiths Medical sent an Urgent Medical Device Correction letter to health provider customers on Dec. 19, 2023. The letter instructed health providers to locate all affected pumps, make pump users aware of the recall, and confirm that all the pumps have the most recent Medfusion software installed. The company asked customers to respond within 10 days of receiving the letter.
The FDA has more information about the recall, including product codes of affected devices, on its website.
ICU Medical completed its $2.35 billion purchase of Smiths Medical in January 2022.
