CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracies (up to 17.5% over/under) that could cause unsafe therapy dosing. 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 doses up to 17.5% too high or too low. 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 could cause over-infusion or under-infusion of therapy, potentially leading to serious health consequences.
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 BodyGuard Microset product with reference number A120-161XPSV. All units within the product's expiry date are affected.
Identify the BodyGuard Microset with reference number A120-161XPSV and check if it's within the product's expiry date.
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 if your BodyGuard Microset has reference number A120-161XPSV and is within the product's expiry date. If affected, contact CME America for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2565-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2565-2020 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.
