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 cause serious harm to patients using the device for medical treatment.
The infusion sets may deliver medication 42.8% less or 17.5% more than intended. This inaccuracy could lead to over-infusion (excess medication) or under-infusion (insufficient medication) during therapy.
Patients using BodyGuard Microset infusion sets for medical therapy are most at risk. The recall affects all units within the product's expiry date.
Check for the product code A120-112XSFK on the BodyGuard Microset. All units within the product's expiry date are included in this recall.
Look for the product code A120-112XSFK on the BodyGuard Microset.
The BodyGuard Microset may deliver medication up to 17.5% more or 42.8% less than prescribed, risking over or under-infusion of therapy.
The recall record does not specify a remedy, so check with CME America for further instructions.
The recall states that use could cause over-infusion or under-infusion of therapy, which may lead to serious harm.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2559-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2559-2020 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.
