CME America recalls BodyGuard Microset with Filter (REF: A12:0-160XSFE) due to potential infusion delivery inaccuracies that could cause over- or under-infusion of therapy.
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 with Filter infusion sets 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 for patients using these devices.
The infusion sets may deliver therapy at up to 17.5% more or 42.8% less than intended. This inaccuracy could cause over-infusion (excessive treatment) or under-infusion (inadequate treatment) of therapy, potentially leading to serious health consequences.
Patients using BodyGuard Microset with Filter infusion sets for therapy are affected. Those with medical conditions requiring precise dosing are at higher risk.
Check for the product name 'BodyGuard Microset with Filter' and reference number A120-160XSFE. All lots within the expiry date are included in this recall.
Identify the product name and reference number on the device packaging.
Reach out to CME America for guidance on next steps if you have the recalled product.
The infusion sets may have delivery inaccuracies ranging from minus 42.8% to plus 17.5% of the intended therapy dose, which could cause over- or under-infusion of treatment.
The official recall notice does not specify a remedy, so contact CME America directly for guidance.
The recall states that use of the infusion pump system could cause over- or under-infusion of therapy, which may lead to serious health consequences.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2571-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2571-2020 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.
