CME America recalls BodyGuard Microset with Needleless Adaptor (REF: A12:003XSNY) due to potential infusion delivery inaccuracies that could cause over or under therapy. Affected units may need replacement.
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 Needleless Adaptor (REF: A120-003XSNY) because it may deliver therapy doses up to 17.5% over or 42.8% under the intended amount. This risk could lead to serious health issues if the device is used without correction.
The infusion sets may deliver therapy doses with an accuracy error of up to 17.5% over or 42.8% under the intended amount. This could cause over-infusion (excess therapy) or under-infusion (insufficient therapy) if the device is used without correction.
Patients using this infusion system for therapy are most at risk. The recall affects all units with the specified reference number within their expiry date.
Check for the reference number A120-003XSNY on the product packaging. The recall covers all units within their expiry date.
Look for the reference number A120-003XSNY on the product packaging to confirm if it is affected.
Yes, the recall indicates potential delivery inaccuracies that could cause over or under therapy, which may lead to serious health issues.
Check for the reference number A120-003XSNY on the product packaging. The recall covers all units within their expiry date.
The recall does not specify a remedy, so contact CME America for guidance on next steps.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2567-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2567-2020 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.
