Mridium MRI Infusion System - Syringe Adapter Set

Finished 1057 sets made with a occluded air pathway will trigger the inlet occlusion alarm of the pump and stop delivery of medication until the inlet occlusion is resolved by replacement of the 1057 IV set. The pump detects the inlet occlusion functions as specified, the occluded air venting pathway is not per specification for the 1057 IV set. This can lead to a hazard situation of a delay of therapy and possible under-dosing which could result in serious adverse health events.

Recall start date: February 27, 2023