Iradimed MRidium MRI Infusion Pump Syringe Adapter Sets Recalled for Occlusion Risk
Iradimed is recalling MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets due to a defective part that can limit venting function and cause occlusion, potentially interrupting medication delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device with a defect that can cause occlusion and interrupt medication delivery. No illnesses or injuries have been reported, making this a risk-of-harm situation without confirmed patient harm.
Plain-English summary
Iradimed Corporation is recalling certain MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets (Reference 1057-50) due to a manufacturing defect in 3,285 boxes of 50 devices each.
The recalled sets contain a defective injection molded part that compromises the syringe venting function. When the venting function fails, occlusion can result—a blockage that prevents fluid from flowing through the adapter and infusion pump. This blockage can interrupt medication delivery.
The affected products were distributed worldwide, including throughout the United States and to 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, South Africa, Spain, Switzerland, Taiwan, Thailand, and United Arab Emirates.
Affected devices bear the UDI DI 10856038001048 and lot numbers including 21K50N, 22A03N, 22A59N, 22B54N, 22D15N, 22D28N, 22D58N, 22I17N, 031851, 22J46N, 032198, 22L02N, and 032822, with expiration dates ranging from November 2023 through January 2025.
The recalled product
- Product
- Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
- Manufacturer
- Iradimed Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI di 10856038001048
- Lot Numbers: 21K50N
- exp. 11/30/2023
- 22A03N
- exp. 01/31/2024
- 22A59N
- exp. 2/29/2024
- 22B54N
- 22D15N
- exp. 4/30/2024
- 22D28N
- 22D58N
- 22I17N
- exp. 9/30/2024
- 031851
- 22J46N
- exp. 10/31/2024
- 032198
- exp. 11/30/2024
- 22L02N
Distribution
Distributed nationwide across the United States.
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