CME America recalls BodyGuard Microset With Female Luer (REF: A12:160XPSN) due to potential infusion delivery inaccuracies that could cause over or under therapy. Affected units may need replacement.
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 Female Luer infusion sets because they may deliver medication at up to 17.5% over or 42.8% under the intended dose. This could lead to serious treatment errors if used without correction.
The infusion sets may deliver medication at up to 17.5% more or 42.8% less than prescribed. This inaccuracy could cause over-infusion (excess medication) or under-infusion (insufficient medication) during therapy.
Patients using this infusion set for medical therapy are affected. Those with critical conditions requiring precise dosing are at higher risk.
Check for the product name 'BodyGuard Microset With Female Luer' and reference number A120-160XPSN. All units within their expiration date are included in this recall.
Identify the product name and reference number on the packaging to confirm if it is affected.
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 dose, which could cause over- or under-infusion of therapy.
Look for the product name 'BodyGuard Microset With Female Luer' and reference number A120-160XPSN on the packaging.
Contact CME America for guidance on next steps, as the recall does not specify a replacement or repair process.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2588-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2588-2020 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.
