CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracies of up to 17.5% over/under therapy. Affected units may cause over or under infusion of medication.
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
CME America is recalling BodyGuard Microset infusion sets that could deliver medication up to 17.5% more or less than prescribed. This risk of incorrect dosing could lead to serious health consequences if the device is used without correction.
The infusion sets may deliver medication up to 17.5% more or less than intended due to a manufacturing defect. This can cause over-infusion (excess medication) or under-infusion (insufficient medication) of therapy, potentially leading to serious health issues.
Patients using the BodyGuard Microset infusion system for medical therapy are most at risk. The recall affects all units within the specified expiry date.
Check for the model reference A120-161XYBS on the product. The recall covers all units within the expiry date as stated in the manufacturer's notice.
Identify the model reference A120-161XYBS and expiry date on the infusion set.
The BodyGuard Microset infusion sets may have delivery inaccuracies of up to 17.5% over or under therapy, which could cause over- or under-infusion of medication.
The recall covers all units within the expiry date. Check the model reference A120-161XYBS and expiry date to confirm if your product is affected.
The recall record does not specify a remedy. Affected users should check with the manufacturer for further instructions.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2563-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2563-2020 from CME America. 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.
