The Recall Desk
ModerateFDA (Devices)·Z-0446-2013·Announced 2012-12-05

Iradimed Recalls MRidium Series 1000 MR Infusion Sets Due to Specification Defect

Iradimed Corporation is recalling 719 MRidium Series 1000 MR Infusion Sets because a section of the device does not meet specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving a specification defect without reported harm.

Plain-English summary

Iradimed Corporation is recalling 719 units of the MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The recall was initiated because a section of the device does not meet specifications.

The affected infusion sets are intended for general hospital or clinical use by medical professionals to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available only by prescription and is not intended for home use.

The recall covers nationwide distribution, including Arizona, California, Florida, Kentucky, Maryland, Massachusetts, New Jersey, New York, Pennsylvania, and Texas. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.

The recalled product

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, d
Manufacturer
Iradimed Corporation
Category
Medical Device — Infusion Set
Hazard
Affected units
719

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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