iRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets. The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, […]
Iradimed
Iradimed withdraws 510(k) application for MR-compatible IV pump
Iradimed (Nasadq:IRMD) announced that it voluntarily withdrew an FDA 510(k) application for its new model MR IV pump. Winter Springs, Florida-based Iradimed said it learned that the FDA likely wouldn’t have time to finish clearance activities for the pending submission. Upon learning this, the company decided to voluntarily withdraw its application on Oct. 5. The […]
iRadimed clears 5-year-old warning letter
iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps. The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, […]
