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U.S. Department of Health and Human Services

Class 2 Device Recall MRidium 1057 MRI Syringe Adapter Set

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 Class 2 Device Recall MRidium 1057 MRI Syringe Adapter Setsee related information
Date Initiated by FirmFebruary 24, 2023
Date PostedMarch 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1310-2023
Recall Event ID 91846
510(K)NumberK050301 K090087 K143369 
Product Classification Pump, infusion - Product Code FRN
ProductIradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Code Information UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N, exp. 2/29/2024; 22D15N, exp. 4/30/2024; 22D28N, exp. 4/30/2024; 22D58N, exp. 4/30/2024; 22I17N, exp. 9/30/2024; 031851, exp. 9/30/2024; 22J46N, exp. 10/31/2024; 032198, exp. 11/30/2024; 22L02N,exp. 12/31/2024; 032822, exp. 1/31/2025
Recalling Firm/
Manufacturer		 Iradimed Corporation
1025 Willa Springs Dr
Winter Springs FL 32708-5235
For Additional Information ContactRoger Susi
407-677-8022
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionIradimed 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 SyringeAdapterRecall@Iradimed.com or via telephone at 407-677-8022.
Quantity in Commerce3285 boxes of 50 devices
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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