CME America recalls T-Syringe Pump Neofeed models with potential under infusion without pump alarm due to motor wear or cracks. Affected units have specific serial numbers and UDI codes.
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
CME America is recalling its T-Syringe Pump Neofeed models because wear on the motor mechanism can cause under-infusion without triggering the pump alarm. Cracks in the pump hardware may also be damaged by cleaning fluids. This could lead to improper medication delivery.
The pump's motor block mechanism can wear out over time, causing under-infusion without the pump alarm sounding. Additionally, cracks in the pump hardware may be damaged during cleaning with fluids, potentially leading to improper medication delivery.
Patients using the T-Syringe Pump Neofeed for medication or fluid infusion are most at risk. The recall affects specific model numbers and serial numbers listed in the official notice.
Check for model numbers 100-109PSL1A, 100-109PSLA, or 100-110PSLA. Look for serial numbers in the list provided in the recall notice. UDI codes include B101100109PSLA0, B101100109SL1A0, and B101100110PSLA0.
Identify your pump model number from the product label to see if it matches the recalled models (100-109PSL1A, 100-109PSLA, or 100-110PSLA).
Check the serial number on your pump against the list of affected serial numbers provided in the recall notice.
The pump's motor block mechanism can wear out, causing under-infusion without the pump alarm sounding. Cracks in the pump hardware may also be damaged by cleaning fluids.
Check your pump model number (100-109PSL1A, 100-109PSLA, or 100-110PSLA) and serial number against the list provided in the recall notice.
The recall does not specify a remedy, so contact CME America directly 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-0528-2021 — CME America CME America Hello, I own a CME America that is covered by recall Z-0528-2021 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.
