CME America recalls CMExpress Microbore Set (REF: A120-160C) for potential infusion delivery inaccuracies that could cause over- or under-infusion of therapy.
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: A120-160C) because it may deliver medication with up to 17.5% error, risking over- or under-dosing. This could lead to serious health consequences for users.
The infusion sets may deliver medication with an error range of up to 17.5% (from minus 42.8% to plus 17.5%). This could cause either over-infusion (too much medication) or under-infusion (too little medication) of therapy, potentially leading to serious health issues.
Patients using the CMExpress Microbore Set for infusion therapy are affected. Those with medical conditions requiring precise medication dosing are at higher risk.
Check for the product name 'CMExpress Microbore Set' and reference number A120-160C. All lots within the expiry date are included in this recall.
Identify the product name and reference number A120-160C on the set.
Reach out to CME America for guidance on next steps.
The recall affects patients using the CMExpress Microbore Set (REF: A120-160C) for infusion therapy. Not all patients are affected.
The product may deliver medication with an error range of up to 17.5%, potentially causing over- or under-infusion of therapy.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2586-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2586-2020 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.
