Health product recall

Mridium MRI Infusion System - Syringe Adapter Set

Last updated

Summary

Product
Mridium MRI Infusion System - Syringe Adapter Set
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Mridium MRI Infusion System - Syringe Adapter Set 22D58N 22A59N 22A03N 22I17N 22J46N 22B54N 1057

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Iradimed Corporation

1025 Willa Springs Drive, Winter Springs, Florida, United States, 32708

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73420