Home » IRadimed Sends Letter Warning of Potential Issues with Syringe Adapter Sets
IRadimed Sends Letter Warning of Potential Issues with Syringe Adapter Sets
Devices Postmarket Safety
IRadimed has issued an Urgent Medical Device Correction letter warning customers about a potential issue with some of its 1057 syringe adapter sets, which deliver IV fluids through the company’s infusion pump.
The syringe venting function in the affected sets can limit flow from the company’s MRidium infusion pump, resulting in an alarm and the infusion being stopped.
The company said it identified a defective injection molded part causing the issue in an estimated 0.4 percent of its recently manufactured infusion sets.
IRadimed said it received five complaints related to the issue but no reports of injuries or deaths.