Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors
Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is…"
Plain-English summary
Iradimed Corporation is recalling 176 units of the MRidium 1145 Dose Reduction System (DERS) drug library kit. This kit is an option for the MRidium 3860+MR Infusion Pump System, which is 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 recall is due to a defect where the DERS can indicate an incorrect recommended value for the infusion rate via a specific key sequence during the initial setup. If an infusion is started with this incorrect rate value, it can result in a risk of over-infusion or under-infusion.
The affected kits were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, Austria, Denmark, France, Germany, the Netherlands, Saudi Arabia, and the United Kingdom. The recall includes specific part number 1145 lots ranging from 4501 to 7213. Medical professionals should stop using the affected kits and contact Iradimed Corporation for further instructions.
The recalled product
- Product
- MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse…
- Manufacturer
- Iradimed Corporation
- Affected units
- 176
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 (20)
- Part number 1145 Lots: 4501
- 4510
- 4538
- 4587
- 4596
- 4675
- 4690
- 4705
- 4738
- 4748
- 4960
- 4970
- 5001
- 5065
- 5104
- 6164
- 5221
- 5240
- 5349
- 5361
Distribution
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