Reported Apr 5, 2023 · Ongoing
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Iradimed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iradimed Corporation · 1025 Willa Springs Dr · Winter Springs, FL · 32708-5235
Is this the product you have?
- Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
- Lot codes and dates
- UDI di 10856038001048
- Lot Numbers
21K50Nexp. 11/30/202322A03Nexp. 01/31/202422A59Nexp. 2/29/202422B54Nexp. 2/29/202422D15Nexp. 4/30/202422D28Nexp. 4/30/202422D58Nexp. 4/30/202422I17Nexp. 9/30/2024031851exp. 9/30/202422J46Nexp. 10/31/2024032198exp. 11/30/202422L02Nexp. 12/31/2024032822exp. 1/31/2025
- Amount recalled
- 3285 boxes of 50 devices
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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