CME America recalls BodyGuard Microset with Filter and Manual Priming Valve (REF: A12:112XSFV) due to potential infusion delivery inaccuracies that could cause over or under therapy administration.
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 Filter and Manual Priming Valve because it may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This risk could lead to serious treatment errors for patients using infusion pumps.
The infusion sets may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This inaccuracy can cause over-infusion or under-infusion of therapy, potentially leading to serious treatment errors.
Patients using the BodyGuard Microset with Filter and Manual Priming Valve for infusion therapy are affected. Those with medical conditions requiring precise dosing are at higher risk.
Check for the BodyGuard Microset with Filter and Manual Priming Valve, reference number A120-112XSFV. All lots within the product's expiry date are included in this recall.
Identify the reference number A120-112XSFV on the product packaging or label.
Reach out to CME America for guidance on next steps if you have the recalled product.
Yes, the recall states that the infusion sets may deliver therapy at up to 17.5% over or 42.8% under the intended dose, which could cause serious treatment errors.
Look for the BodyGuard Microset with Filter and Manual Priming Valve, reference number A120-112XSFV on the product packaging or label.
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-2583-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2583-2020 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.
