CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracies of up to 17.5% over 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 for users.
The infusion sets may have delivery inaccuracies ranging from minus 42.8% to plus 17.5% of the intended medication dose. This means the system could deliver too much or too little therapy, potentially causing serious health issues.
Patients using the BodyGuard Microset infusion system with the reference number A100-163XESV are most at risk. Healthcare providers administering these sets to patients also need to be aware.
Check for the reference number A100-163XESV on the infusion set packaging. All units within the expiry date are affected by this recall.
Look for the reference number A100-163XESV on the packaging to confirm if your unit is affected.
The BodyGuard Microset may deliver medication up to 17.5% more or less than prescribed, potentially causing over- or under-infusion of therapy.
Check for the reference number A100-163XESV on the packaging. All units within the expiry date are affected.
The recall record does not specify a remedy, so contact CME America directly for guidance.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2555-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2555-2020 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.
