CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracies of up to 17.5% over therapy. Affected units may cause over or under infusion of medication.
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 with a non-vented spike connector that could deliver medication up to 17.5% more or less than prescribed. This risk of incorrect dosing could lead to serious health consequences if the device is used without proper adjustment.
The infusion sets may have delivery inaccuracies ranging from minus 42.8% to plus 17.5% of the intended dose. This means the device could deliver too much or too little medication during therapy, potentially causing serious health issues.
Patients using the BodyGuard Microset infusion system with the specific model reference A100-163XEBS are most at risk. Healthcare providers administering these devices to patients also need to be aware of the potential for inaccurate medication delivery.
Check for the model reference A100-163XEBS on the BodyGuard Microset infusion set. The recall covers all lots within the product's expiry date.
Verify the model reference A100-163XEBS on the BodyGuard Microset infusion set.
No, this recall specifically affects the BodyGuard Microset with model reference A100-163XEBS.
The infusion sets may deliver medication up to 17.5% more or less than prescribed, potentially causing over or under infusion of therapy.
The recall record does not specify a remedy or replacement process.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2570-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2570-2020 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.
