ICU Medical recalls oncology kits with potential port leaks. Affected kits may leak during use, causing drug exposure. Stop using immediately if you have the kit.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling oncology kits that may leak during use due to a port weld issue. This could lead to drug exposure if the port breaks. Affected users should stop using the kit immediately.
The port weld in the drug transfer device can separate or break during use. This may cause a leak of chemotherapy drugs, potentially exposing users to harmful substances.
Patients receiving chemotherapy through this kit are most at risk. Healthcare providers using the kit for drug administration may also be affected.
Check for the kit model CL4188 with lot number 14369087. The product was distributed in Canada.
Immediately stop using the recalled oncology kit if you have it.
Yes, the port weld may break during use, causing a leak of chemotherapy drugs.
Check for model CL4188 with lot number 14369087. The kit was distributed in Canada.
Stop using it immediately and contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0362-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0362-2026 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.
