CME America recalls BodyGuard Microset infusion sets with potential delivery inaccuracy of up to 17.5% over therapy, risking over or under-infusion. Affected units include specific model and 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 that may deliver therapy at up to 17.5% over or under the intended dose. This could cause serious harm to patients using the device for medical treatment.
The infusion sets may have delivery inaccuracy ranging from minus 42.8% to plus 17.5% of the intended therapy dose. This means the device could deliver too much or too little medication, potentially causing serious harm to patients.
Patients using the BodyGuard Microset infusion sets for medical therapy are most at risk. The recall affects all units with the specific model and lot numbers within expiry dates.
Check for the model number A120-160XYBF on the product. The recall includes all lots within the expiry date.
Look for the model number A120-160XYBF on the product label.
Yes, the recall states the infusion sets may deliver therapy at up to 17.5% over or under the intended dose, which could cause serious harm.
Check for the model number A120-160XYBF on the product label. The recall includes all lots within the expiry date.
The recall does not specify a remedy, so contact CME America for further instructions.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2584-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2584-2020 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.
