CME America recalls CMExpress Needleless Y Site Microb: sets with delivery inaccuracy over 13% that could cause over or under infusion of therapy. Affected units include all lots within expiry.
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 Needleless Y Site Microbore Set because it may deliver medication with up to 17.5% error, risking over or under treatment. This could lead to serious health issues if the device is used without correction.
The infusion sets may have delivery inaccuracies of up to 17.5% in some cases, meaning medication could be delivered too much or too little. This risk is highest when the device is used for critical treatments where precise dosing is essential.
Patients using the CMExpress Needleless Y Site 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 Needleless Y Site Microbore Set' with reference number A120-160CYNVK. All lots within expiry date are affected.
Identify the product name and reference number to confirm if it is affected.
Reach out to CME America for guidance on next steps if you have the affected product.
The product may have delivery inaccuracies that could cause over or under infusion of therapy, so it is not safe to use without verification.
Check for the product name 'CMExpress Needleless Y Site Microbore Set' with reference number A120-160CYNVK. All lots within expiry date are affected.
Contact CME America for guidance on next steps if you have the affected product.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2587-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2587-2020 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.
