CME America recalls CMExpress Microbore Set (REF: A120-160CRV) due to potential infusion delivery inaccuracies of up to 17.5% over therapy, risking over or under-dosing.
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 its CMExpress Microbore Set (REF: A120-160CRV) because it may deliver therapy doses up to 17.5% too high or too low. This could lead to serious health risks if used for medical infusion treatments.
The infusion sets may deliver therapy doses with an accuracy error of up to 17.5% (ranging from minus 42.8% to plus 17.5%). This could cause over-infusion (excess medication) or under-infusion (insufficient medication) during treatment.
Patients using this infusion set for medical therapy are affected. Those with critical health conditions requiring precise dosing are at higher risk.
Check for the model reference A120-160CRV on the product packaging. The recall covers all lots within the product's expiration date.
Look for the model reference A120-160CRV on the product packaging or expiration date.
The recall indicates potential delivery inaccuracies that could cause over or under-infusion of therapy, so it is not safe to use without replacement.
Using this set could lead to incorrect medication dosing, which may cause serious health risks depending on the treatment.
The recall does not specify a remedy, so contact CME America directly for guidance on next steps.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2568-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2568-2020 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.
