Merit Medical recalls certain Maestro Microcatheter models due to potential sterility issues. Affected devices may not be sterile, risking infection during medical procedures. Contact Merit Medical for details.
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Merit Medical is recalling specific models of Maestro Microcatheter devices because they may not be sterile. This could lead to infections if used in medical procedures. Affected devices have reference numbers listed in the recall notice.
The recall states that the sterility of the microcatheter and infusion system devices cannot be guaranteed. This means the devices might not be sterile, which could lead to infections during medical procedures if used improperly.
Healthcare professionals and medical facilities that use the Merit Maestro Microcatheter devices are most at risk. Patients using these devices during procedures could face infection risks if the devices are not properly sterile.
Check the reference numbers on the device: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, and other listed models. The devices are labeled as CE 2797, STERILEEO, Rx ONLY.
Look for reference numbers such as 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, or 28MC21130SN/CNB on the device packaging or label.
The recall states that the sterility of the microcatheter and infusion system devices cannot be guaranteed, which could lead to infections during medical procedures.
Check the reference numbers on the device: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, and other listed models. The devices are labeled as CE 2797, STERILEEO, Rx ONLY.
The recall does not specify a remedy, so contact Merit Medical directly for instructions on how to handle affected devices.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0627-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0627-2024 from Merit Medical. 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.
