CME America recalls BodyGuard Microset with Male Luer Connectors (REF A100-163XEBF) due to potential infusion delivery inaccuracies that could cause over or under therapy administration.
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 Male Luer Connectors because they may deliver medication at up to 17.5% over or 42.8% under the intended dose. This risk could lead to serious treatment errors if used without proper calibration.
The infusion sets may deliver medication at up to 17.5% over or 42.8% under the intended dose. This inaccuracy could cause over-infusion or under-infusion of therapy, potentially leading to serious treatment errors.
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 Male Luer Connectors' and reference number A100-163XEBF. All lots within expiry date are included in this recall.
Identify the reference number A100-163XEBF on the product packaging to confirm if it's affected.
The recall indicates potential delivery inaccuracies that could cause over or under therapy administration, so it is not safe to use without replacement.
The recall record does not specify a replacement process or contact information.
The recall states that use could cause over-infusion or under-infusion of therapy, which may lead to serious treatment errors, but does not specify injury cases.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2581-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2581-2020 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.
