CME America recalls BodyGuard Microset (A100-163XSFL) due to potential infusion delivery inaccuracies that could cause over or under therapy. All lots within expiry are affected.
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 serial number A100-163XSFL 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 deliver therapy doses that are 13% inaccurate, ranging from 42.8% under to 17.5% over the intended amount. This can cause either over-infusion (excess medication) or under-infusion (insufficient medication) of therapy, potentially leading to serious health consequences.
Patients using the BodyGuard Microset infusion system with the serial number A100-163XSFL are affected. Those with chronic conditions requiring precise medication dosing are at higher risk.
Check for the serial number A100-163XSFL on the BodyGuard Microset infusion sets. All lots within the expiry date are included in this recall.
Look for the serial number A100-163XSFL on the BodyGuard Microset infusion sets.
The BodyGuard Microset may deliver therapy doses that are 13% inaccurate, ranging from 42.8% under to 17.5% over the intended amount.
Check for the serial number A100-163XSFL on the BodyGuard Microset infusion sets. All lots within the expiry date are affected.
The recall record does not specify a remedy, so contact CME America directly for guidance.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2560-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2560-2020 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.
