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.
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 serious harm to patients using the device for medical treatment.
The infusion sets may have delivery inaccuracies of up to 17.5% (ranging from minus 42.8% to plus 17.5%). This can lead to over-infusion or under-infusion of therapy, potentially causing serious harm to patients.
Patients using BodyGuard Microset infusion sets for medical therapy are most at risk. The recall affects all units within the product's expiry date.
Check for the product name 'BodyGuard Microset' and reference code 'A120-160X2YB'. All units within the product's expiry date are affected.
Identify the product name and reference code on the device to confirm if it matches the recalled BodyGuard Microset (A120-160X2YB).
Reach out to CME America for guidance on next steps if you have the recalled product.
The BodyGuard Microset infusion sets may have delivery inaccuracies of up to 17.5% (ranging from minus 42.8% to plus 17.5%), which could cause over-infusion or under-infusion of therapy.
Check for the product name 'BodyGuard Microset' and reference code 'A120-160X2YB'. All units within the product's expiry date are affected.
Contact CME America for guidance on next steps if you have the recalled product.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2566-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2566-2020 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.
