CME America recalls BodyGuard Microset (REF: A12:160GCFA) due to potential infusion delivery inaccuracies that could cause over or under therapy. 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 because they may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This risk of incorrect dosing could lead to serious health consequences for users.
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 either over-infusion (excessive therapy) or under-infusion (inadequate therapy) leading to health risks.
Patients using the BodyGuard Microset for therapy administration 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 'A120-160GCFA'. All units within the product's expiry date are affected.
Verify the product name and reference code on the device to confirm if it matches the recalled BodyGuard Microset (REF: A120-160GCFA).
The recall affects all BodyGuard Microset units with reference code A120-160GCFA within the product's expiry date. Check your device details to confirm.
The recall does not specify a remedy, so check with CME America for guidance on next steps.
The recall states that incorrect dosing could lead to over or under therapy, which may cause health risks. However, the specific risk level is not detailed in the notice.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2577-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2577-2020 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.
