Recall Z-1310-2023— Iradimed Corporation
Class II · Ongoing
Class II FDA medical device recall by Iradimed Corporation, initiated 2023-02-24. It names 3 FDA 510(k) clearances: K143369, K090087, K050301. Product: Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,. Reason: 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..
- Recalling firm
- Iradimed Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-24
- Firm location
- Winter Springs, FL, United States
510(k) clearances named in this recall
3 on FDA's record- K143369 — MRidium 3860+ MRI infusion Pump/ Monitoring System
- K090087 — MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
- K050301 — MRIDIUM 3850 MRI PUMP SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.