ICU Medical recalls 6" ext sets with ChemoLock port for potential leak if port weld breaks during use. Affected units sold in Canada.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling 6-inch extension sets with a ChemoLock port due to a risk of the port weld separating and leaking during use. This could cause medication to leak out of the system, potentially affecting patient safety.
The port weld in the drug transfer device may break or separate during use, causing medication to leak. This leak could lead to incorrect dosing or contamination of the patient's treatment.
Healthcare professionals using these medical devices in Canada are most at risk. Patients receiving treatment with these devices could be affected if the leak occurs.
Check for the model number CL4118 on the device. The product was distributed in Canada with specific lot numbers: 14393173 and 14409213.
Inspect the ChemoLock port for signs of separation or leakage after use.
The product may have a risk of port weld separation causing leaks, so it's recommended to check for leaks before use.
Look for the model number CL4118 on the device. The product was distributed in Canada with specific lot numbers: 14393173 and 14409213.
The recall does not specify a remedy, so check for leaks and contact ICU Medical if you find any issues.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0361-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0361-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
