Class II — Iradimed Corporation
| Recalling firm | IRADIMED CORPORATION |
|---|---|
| Registered facility | IRADIMED CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications. |
| Product | The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to in… |
| Quantity | 719 sets |
| Distribution | Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX. |
| Initiated | 2012-08-24 |
| Classified | 2012-11-28 |
| Terminated | 2013-07-19 |
| Recall number | Z-0446-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Iradimed Corporation (Z-0446-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63675/
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