CME America recalls T34L PCA syringe pumps with serial numbers 26484-26486 and UDI code B101100106PSL0 due to risk of under infusion without pump alarm. Affected users should contact CME America for details.
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 T34L PCA syringe pumps that may cause under-infusion of medications without triggering the pump alarm. This could lead to dangerous medication levels if the pump fails during use.
The pump's motor block mechanism can wear out, causing under-infusion without the alarm sounding. Cracks in the pump hardware may also be damaged by cleaning fluids, leading to potential failure.
Patients using medical syringe pumps for continuous or intermittent medication delivery are most at risk. Healthcare providers and patients with specific medical conditions requiring precise infusion rates may be affected.
Check for serial numbers 26484, 26485, or 26486 on the pump. The UDI code B101100106PSL0 is also associated with these models.
Reach out to CME America for specific instructions on how to handle the recalled pump.
The pump may cause under-infusion of medications without triggering the alarm, leading to dangerous medication levels if the pump fails.
Check for serial numbers 26484, 26485, or 26486 or UDI code B101100106PSL0 on the pump.
Contact CME America for specific instructions on handling the recalled pump.
We’ve drafted a message you can send CME America to request your refund or repair — edit it as you like.
Subject: Recall Z-0527-2021 — CME America CME America Hello, I own a CME America that is covered by recall Z-0527-2021 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.