CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracies up to 17.5% over/under therapy. Affected units may cause 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 could deliver medication up to 17.5% more or less than prescribed. This risk of incorrect dosing could lead to serious health consequences if the device is used without correction.
The infusion sets may deliver medication up to 17.5% more or less than prescribed due to a manufacturing defect. This can cause either over-infusion (too much medication) or under-infusion (too little medication) of therapy, potentially leading to serious health issues.
Patients using the BodyGuard Microset infusion sets for medical therapy are most at risk. Healthcare providers administering these sets to patients may also be affected.
Check for the product name 'BodyGuard Microset' with a 0.2 mic filter and lower y-site with female luer. The reference number A120-160CYFRV is on the packaging. All lots within expiry date are affected.
Verify the product name, reference number, and expiry date on the packaging to confirm if it's affected.
The BodyGuard Microset infusion sets may have delivery inaccuracies up to 17.5% over or under prescribed therapy doses, which could cause over- or under-infusion of medication.
The recall record does not specify a remedy, so check the product details to confirm if it's affected and contact CME America for further instructions.
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 if not corrected.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2589-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2589-2020 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.
