CME America recalls BodyGuard Microset (REF: A100-163XES) due to potential infusion delivery inaccuracies that could cause over or under therapy. All lots within expiry date are affected.
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 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 calibration.
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 infusion system for therapy are affected. Those with medical conditions requiring precise dosing are at higher risk.
Check for the BodyGuard Microset with reference number A100-163XES. All lots within the expiry date are included in this recall.
Identify the BodyGuard Microset with reference number A100-163XES and check if it's within the expiry date.
No, this recall specifically affects BodyGuard Microset with reference number A100-163XES and all lots within the expiry date.
Yes, the infusion sets may deliver therapy at up to 17.5% over or 42.8% under the intended dose, which could lead to serious treatment errors.
Check the product details to see if it's affected. If it is, contact CME America for further instructions.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2556-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2556-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
