Iradimed recalls MRI 1000 Series infusion sets with defective syringe adapter that may cause occlusion due to venting issues. Check product details and contact for replacement.
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.
Iradimed is recalling certain MRI 1000 Series infusion sets with a defective syringe adapter that could cause blockages. This affects patients using the device for medical treatments.
The syringe adapter has a defective part that can limit the syringe's venting function. This may lead to blockages in the infusion system, potentially causing treatment interruptions.
Patients using the Iradimed MRI 1000 Series infusion pumps with the recalled syringe adapter sets are most at risk. The issue is specific to the adapter's venting function.
Check for the model number REF 1057-50 on the adapter. The product was sold with specific lot numbers and expiration dates listed in the recall notice.
Identify the adapter model and lot numbers from the recall notice to confirm if your product is affected.
The syringe adapter has a defective part that can limit the syringe venting function, potentially causing blockages in the infusion system.
Check for the model number REF 1057-50 and the specific lot numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Iradimed Corporation directly for further instructions.
We’ve drafted a message you can send Iradimed to request your refund or repair — edit it as you like.
Subject: Recall Z-1310-2023 — Iradimed Iradimed Hello, I own a Iradimed that is covered by recall Z-1310-2023 from Iradimed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
