CME America recalls CMExpress Microbore Sets (REF: A120-160CYFRV) due to potential delivery inaccuracy of up to 17.5% in infusion 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 CMExpress Microbore Sets with serial number A120-160CYFRV because they may deliver therapy doses incorrectly by up to 17.5%. This could lead to harmful over- or under-infusion of medication, which is serious for patients using these sets.
The sets may deliver medication doses inaccurately by up to 17.5% (ranging from minus 42.8% to plus 17.5%). This can cause either over-infusion (too much medication) or under-infusion (too little medication) during therapy, which could lead to serious health issues.
Patients using CMExpress Microbore Sets for infusion therapy are most at risk. The recall affects all units within the product's expiry date.
Check for the product reference number A120-160CYFRV on the sets. The recall covers all units produced within the product's expiry date.
Look for the reference number A120-160CYFRV on the infusion sets to confirm if they are affected.
The sets may have delivery inaccuracy of up to 17.5% in infusion therapy, which could cause over- or under-dosing of medication.
Check for the reference number A120-160CYFRV on the sets. The recall covers all units within the product's expiry date.
The recall does not specify a remedy, so contact CME America 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-2578-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2578-2020 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.
