FDA Device recall Z-1310-2023
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50 by Iradimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1310-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-24 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Iradimed |
| Distribution | US |
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.
Identifiers
| code_info | UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1310-2023%22
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