CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracies of up to 13% over/under, risking incorrect therapy dosing. Affected units include all lots within expiry date.
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 therapy doses up to 13% more or less than intended. This could lead to over- or under-infusion of medication, which might cause serious health issues.
The infusion sets may have delivery inaccuracies of up to :13% over or under the intended dose. This can happen during therapy administration, potentially causing over-infusion (too much medication) or under-infusion (too little medication).
People using the BodyGuard Microset for medical infusion therapy are affected. Those with critical health conditions requiring precise dosing are at higher risk.
Check for the BodyGuard Microset product with reference number A120-160XPS. All lots within the expiry date are affected.
Identify the reference number A120-160XPS on the product packaging to confirm if it's affected.
The recall affects all BodyGuard Microset units with reference number A120-160XPS within expiry date. If you use this product, you should check if it's affected.
The recall record does not specify a remedy, so you should contact CME America directly for guidance.
The product may have delivery inaccuracies ranging from minus 42.8% to plus 17.5% of the intended dose, potentially causing over- or under-infusion.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2554-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2554-2020 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.
