The brand name is MRidium Series 1000 MR Infusion Sets… recallZ-0446-2013 · Iradimed Corporation · initiated Aug 24, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Iradimed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Iradimed Corporation contacted all affected customers directly by phone, and followed up with an email notification. Customers were instructed to return the product to Iradimed Corporation. For questions regarding this recall call 407-677-8022.
Recall details
- Recall number
- Z-0446-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 24, 2012
- Posted by the FDA
- Nov 28, 2012
- Recalling firm
- Iradimed Corporation
- Quantity
- 719 sets
- Product code
- FRN
- FDA submissions
- K050301
- Distribution
- Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
Product description
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 infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
Code information (models, lots, serial numbers)
The device Lot Code is LBG001. The "L" indicates facility, Las Piedras Facility. The "B" indicates year manufactured, 2012. The "G" indicates month manufactured, July. The "001" indicates the sequential lot build, restarts at 1 every month.
Other devices under the same FDA submission
2 devices cleared under K050301 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Iradimed 1057Iradimed Corp. · Pump, Infusion1 recall7 reports
- Iradimed 1056Iradimed Corp. · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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