CME America recalls BodyGuard infusion sets with Female Luer (REF A12:003XSN) due to potential delivery inaccuracies of up to 17.5% over therapy doses, risking over or under-infusion.
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 BodyGuard infusion sets with Female Luer (REF A120-003XSN) because they may deliver therapy doses up to 17.5% too high or too low, which could cause harmful over- or under-infusion of medication.
The infusion sets may have delivery inaccuracies of up to 17.5% (ranging from minus 42.8% to plus 17.5%). This means the system could deliver too much or too little therapy, potentially causing serious harm if the medication is critical.
Patients using the BodyGuard infusion system with the Female Luer connector are most at risk, particularly those receiving critical therapy doses where precise delivery is essential.
Check for the BodyGuard set with Female Luer connector and reference number A120-003XSN. All lots within the product's expiration date are affected.
Identify the reference number A120-003XSN on the BodyGuard set with Female Luer connector.
Reach out to CME America for guidance on next steps if you have the recalled product.
No, only BodyGuard sets with Female Luer connector and reference number A120-003XSN are affected.
Patients using the recalled sets risk receiving incorrect therapy doses, which could lead to over- or under-infusion of medication.
Check the reference number on your product and contact CME America for further instructions.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-2582-2020 — CME America CME America Hello, I own a CME America that is covered by recall Z-2582-2020 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.
