CME America recalls T34 T-Syringe Pump models with serial numbers 58771-58999 and others due to pump motor block mechanism wear causing under infusion without alarm. This may lead to medication underdosing.
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 T34 T-Syringe Pumps that may cause under-infusion of medications without triggering the pump alarm. This could lead to patients receiving less medication than intended. The recall covers specific serial numbers and part numbers.
The pump's motor block mechanism can wear over time, causing under-infusion situations without the pump alarm sounding. Additionally, cracks in the pump hardware may be damaged during cleaning with fluids, potentially leading to malfunction.
Patients using the T34 T-Syringe Pump for medication delivery, especially those requiring continuous or intermittent infusion. Individuals with the listed serial numbers or part numbers are most at risk.
Check for the T34 model with serial numbers listed in the recall (e.g., 58771-58999) or part numbers 100-100PS, 100-100PSA, 100-100POBSC, 100-101PS. The product is used for infusion of medications or fluids requiring precise delivery.
Look for the serial number on the pump, which may be in the range 58771 to 58999 or other listed numbers.
Reach out to CME America for specific model and serial number verification if needed.
The T34 T-Syringe Pump is used for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled rates through clinical routes like intravenous, subcutaneous, and surgical sites.
Affected part numbers include 100-100PS, 100-100PSA, 100-100POBSC, 100-101PS.
No, but you should check if your pump is in the recall list. If it is, 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-0530-2021 — CME America CME America Hello, I own a CME America that is covered by recall Z-0530-2021 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.
