CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracy of up to 17.5% over therapy, risking over or under-infusion. Affected units include all lots within expiry date.
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 may deliver therapy at up to 17.5% over or under the intended dose. This could cause harmful over- or under-infusion of medication, especially for patients using these devices regularly.
The infusion sets may have delivery inaccuracy ranging from minus 42.8% to plus 17.5% of the intended therapy dose. This means the device could deliver too much or too little medication, potentially causing serious health issues.
Patients using BodyGuard Microset infusion sets for therapy are most at risk. The recall applies to all units within the product's expiry date.
Check for the product name 'BodyGuard Microset' and reference code 'A120-160XYSF'. All units within the product's expiry date are affected.
Identify the reference code 'A120-160XYSF' and expiry date on the device packaging.
The infusion sets may have delivery inaccuracy ranging from minus 42.8% to plus 17.5% of the intended therapy dose, risking over- or under-infusion of medication.
Check for the reference code 'A120-160XYSF' and the product's expiry date on the packaging.
The recall record does not specify a remedy, so contact CME America directly for guidance.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2561-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2561-2020 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.
