CME America recalls Standard BodySet with Needleless Connectors (REF: A120-125XS) due to potential infusion accuracy issues that could cause over or under delivery 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 Standard BodySet with Needleless Connectors (REF: A120-125XS) because the infusion sets may deliver therapy at up to 17.5% over or 42.8% under the intended dose. This could lead to serious treatment errors for patients using infusion pumps.
The infusion sets may have delivery inaccuracies of up to 17.5% over or 42.8% under the intended dose. This can cause over-infusion or under-infusion of therapy when used with infusion pumps, potentially leading to serious treatment errors.
Patients using the Standard BodySet with Needleless Connectors (REF: A120-125XS) for infusion therapy are affected. Those with medical conditions requiring precise medication delivery are at higher risk.
Check for the product name 'Standard BodySet with Needleless Connectors' and reference number A120-125XS. The recall covers all lots within the product's expiry date.
Identify the reference number A120-125XS on the product packaging to confirm if it is recalled.
The recall indicates potential infusion accuracy issues that could cause over or under delivery of therapy, so it is not safe to use without replacement.
Look for the product name 'Standard BodySet with Needleless Connectors' and reference number A120-125XS on the packaging.
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-2585-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2585-2020 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.
