Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
FDA Recall Z-1310-2023 · Posted 2023-03-30
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Recalling FirmIradimed Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2023-02-24
Product Quantity3285 boxes of 50 devices
Reason for Recall
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.
Firm Action
Iradimed Corporation issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/24/2023 by certified mail. The notice explained the issue and the risk and provided updated instructions for use to mitigate the potential risk of inlet occlusion.
For further information concerning this issue or have any questions, please contact Iradimed support via email at [email protected] or via telephone at 407-677-8022.
Root Cause
Process control
Distribution Pattern
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 Africa, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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