CME America recalls CMExpress Microbore Sets (REF: A120-161C) due to potential delivery inaccuracies causing over or under infusion of 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 CMExpress Microbore Sets (REF: A120-161C) because they may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This could lead to serious health risks if used for medical infusion.
The sets may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This can cause over-infusion or under-infusion of therapy, potentially leading to serious health consequences.
Patients using these infusion sets for medical therapy are affected. Those with specific medical conditions requiring precise dosing are at higher risk.
Check for the product name 'CMExpress Microbore Sets' and reference number A120-161C. All lots within expiry are included in this recall.
Identify the reference number A120-161C on the product packaging.
The sets may have delivery inaccuracies ranging from minus 42.8% to plus 17.5% of the intended dose, which could cause over or under infusion of therapy.
Look for the product name 'CMExpress Microbore Sets' and reference number A120-161C on the packaging. All lots within expiry 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-2580-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2580-2020 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.
