ICU Medical recalls 45" smallbore extension sets with potential port weld leaks. Affected units have specific model and lot numbers. 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 a specific type of medical tubing set due to a risk that the drug transfer port weld could break during use, causing leaks. This could lead to medication errors or contamination if the leak occurs.
The port weld in the drug transfer device may separate or break during use, which could cause medication leaks. This might lead to incorrect dosing or contamination of the patient's treatment.
Healthcare professionals using this specific medical tubing set for chemotherapy administration are most at risk. Patients receiving treatment through this equipment could be affected if the leak occurs.
Check for the model number CL4151 and lot number 14400230 on the product. This specific tubing set is used for chemotherapy administration in hospitals.
Discontinue use of the affected tubing set to prevent potential leaks and medication errors.
No, the product is not safe to use as the port weld may break during use, causing leaks.
Stop using it immediately and contact ICU Medical for further instructions.
Look for model number CL4151 and lot number 14400230 on the product label.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0338-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0338-2026 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.
