Smiths Medical, a Minneapolis-based medical device-maker, is recalling its Medfusion syringe pumps after discovering a software issue that could cause the pumps' low battery alarms to stop working.
The FDA classified the recall as Class I, the most serious type. Use of the devices could cause serious injury or death, the agency warned.
The product being recalled is Smiths Medical's ASD Medfusion 4000 Syringe Pump, which is used to deliver blood, blood products or prescription drugs into a patient's body.
The pumps are typically used in neonatal and pediatric patients and in operating rooms and intensive care units for adults.
Smiths Medical discovered the software issue in the pumps. If the alarms don't work, healthcare providers won't know the battery is shutting down, which could lead to interruption of therapy, causing serious injury, adverse events or death.
Smiths Medical has received 74 complaints related to the issue, but no injuries or deaths have been reported.
All of the affected pumps must be returned to Smiths Medical.
Read the full news release here.