CME America recalls BodyGuard Microset with Filter (REF: A100-163XESF) 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 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 if used without proper adjustment.
The infusion sets may deliver therapy 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 the BodyGuard Microset with Filter for infusion 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 A100-163XESF. All units within the expiry date are affected.
Identify the reference number A100-163XESF on the product packaging to confirm if it is affected.
The recall affects all units of BodyGuard Microset with Filter with reference number A100-163XESF within the expiry date.
The recall record does not specify a remedy, so contact CME America directly for guidance.
The recall states that use could cause over-infusion or under-infusion of therapy, which may lead to serious treatment errors.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2564-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2564-2020 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.
