CME America recalls BodyGuard BodySet (REF: A12:0-160SAS) due to potential infusion delivery inaccuracies that could cause over or under therapy. 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 BodySet infusion sets because they may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This risk could lead to serious health issues if the device is used without correction.
The infusion sets may have delivery inaccuracies of up to 17.5% over or 42.8% under the intended dose. This can cause over-infusion or under-infusion of therapy, potentially leading to serious health consequences.
Patients using the BodyGuard BodySet infusion system for therapy are affected. Those with medical conditions requiring precise dosing are at higher risk.
Check for the BodyGuard BodySet with reference number A120-160SAS. All units within the expiry date are affected.
Identify the reference number A120-160SAS on the product label to confirm if it is affected.
The BodyGuard BodySet infusion sets may have delivery inaccuracies of up to 17.5% over or 42.8% under the intended dose, which could cause over- or under-infusion of therapy.
Check the reference number A120-160SAS on the product label. If affected, contact CME America for guidance.
The recall record does not specify a remedy, so affected users should contact CME America directly for assistance.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2553-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2553-2020 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.
