Iradimed Corporation MRidium MRI 1000 Series Infusion Sets recalled over mold contamination

Recall date

February 24, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Iradimed Corporation recalls Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

Recall number

Z-1310-2023

FDA classification

Class II

Brand / firm

Iradimed Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Austria, Canada, Chile, Denmark, Germany, Great Britain, Hong Kong, Indonesia, Italy, Korea, Kuwait, Malaysia, Netherlands, Nicaragua, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Singapore, Singapore, South…

Why it was recalled

Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,