CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracy of up to 17.5% over therapy, risking 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 may deliver medication up to 17.5% more or less than prescribed. This could lead to serious treatment errors if used without correction.
The infusion sets may have delivery inaccuracy ranging from minus 42.8% to plus 17.5% of the intended dose. This means the actual medication delivered could be significantly higher or lower than prescribed, potentially causing treatment errors.
Patients using the BodyGuard Microset infusion system for medical therapy are most at risk. The recall affects all units within the product's expiry date.
Check for the product name 'BodyGuard Microset' and reference number A100-163XE90S. All units within the product's expiry date are affected.
Identify the product name and reference number on the packaging or label.
Reach out to CME America for guidance on next steps if you have the recalled product.
The recall indicates potential delivery inaccuracy, so it is not safe to use without verification.
Check for the product name 'BodyGuard Microset' and reference number A100-163XE90S on the packaging or label.
Contact CME America for guidance on next steps if you have the recalled product.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2573-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2573-2020 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.
