CME America recalls BodyGuard Microset (A120-125XSE) due to potential infusion delivery inaccuracies that could cause over or under therapy. Affected units include all lots within expiry.
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 with model reference A12:0-125XSE because they may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This risk could lead to serious treatment errors if used without correction.
The infusion sets may deliver therapy doses that are 13% inaccurate, ranging from 42.8% under to 17.5% over the intended amount. This can cause over-infusion or under-infusion of therapy, potentially leading to serious health consequences.
Patients using the BodyGuard Microset infusion system for medical therapy are affected. Those with critical health conditions requiring precise dosing are at higher risk.
Check for the model reference A120-125XSE on the product. All lots within the expiry date are affected by this recall.
Identify the model reference A120-125XSE and expiry date on the infusion set.
The BodyGuard Microset may deliver therapy doses with up to 17.5% over or 42.8% under the intended amount, risking over or under infusion of therapy.
Look for the model reference A120-125XSE on the product, and all lots within the expiry date are affected.
The recall record does not specify a remedy, so contact CME America 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-2576-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2576-2020 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.
