ICU Medical recalls Plum Duo Infusion Pumps with specific list numbers and software versions due to potential flush errors during piggyback therapy that may prevent treatment. Affected units must be checked for error messages.
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
ICU Medical is recalling certain Plum Duo Infusion Pumps that may show error messages when programming a piggyback flush, which could prevent the flush from completing. This might lead to incomplete therapy if the pump fails to flush the line properly.
The pump may display an error message when programming a piggyback flush, preventing the flush from completing. This could lead to incomplete therapy if the pump fails to flush the line properly after piggyback therapy ends.
Healthcare providers using ICU Medical Plum Duo Infusion Pumps with the listed model numbers and software versions are affected. Patients receiving treatment with these pumps may be at risk if the flush fails to complete.
Check for list numbers 400020401 (US) or 400021001 (Philippines) and software versions 1.1.0 to 1.1.4. The pump may show an error message when programming a piggyback flush.
Look for Upper Hard Limit (UHL) or Lower Hard Limit (LHL) violation messages when programming a piggyback flush.
The pump may display an error message when programming a piggyback flush, preventing the flush from completing. This could lead to incomplete therapy if the flush fails to occur.
Software versions 1.1.0 to 1.1.4 for US units and 1.1.0 for Philippine units.
No, but you should check for error messages when programming a piggyback flush to ensure the flush completes properly.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1118-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1118-2026 from ICU Medical. 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.
