ICU Medical recalls 31" admin sets with potential port weld leaks. Affected units sold in Canada; stop using immediately to prevent leaks.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling certain 31-inch IV admin sets because the drug transfer device's port weld might break during use, causing leaks. This could lead to medication exposure or contamination risks for patients.
The port weld in the drug transfer device may separate or break during use, potentially causing leaks. This could lead to medication exposure or contamination risks for patients.
Healthcare professionals using the recalled admin sets in Canada are most at risk. Patients receiving IV treatments with these devices could face contamination or medication exposure.
Check for the purple cap and 'Spiros' on the admin set. Affected units have reference number CL3951 and lots 14397353 or 14418912. These were distributed in Canada.
Discontinue use of the recalled admin set to prevent leaks and potential medication exposure.
No, the port weld may break during use, causing leaks. Stop using immediately.
Stop using it immediately and contact ICU Medical for a replacement or refund.
This product was distributed in Canada.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0359-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0359-2026 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.
