ICU Medical recalls ChemosafeLock Connecter REF KL-FNU3 with potential port weld leaks. Affected units distributed in Japan; stop using if leaks occur.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemosafeLock Connecters with model KL-FNU3 due to a risk that the port weld may separate or break during use, causing leaks. This could lead to medication exposure or contamination in medical settings.
The port weld in the drug transfer device can separate or break during use, potentially causing medication leaks. This could lead to contamination or exposure risks for healthcare workers and patients.
Healthcare professionals using the ChemosafeLock Connecter in Japan for medical drug transfers are most at risk. Patients receiving treatments through this device may also be affected if leaks occur.
Check for the model number KL-FNU3 on the device. Units distributed in Japan with specific lot numbers (14399518, 14399521, 14406408, 14399520, 14406410, 14406411) are affected.
Inspect the device for any signs of leakage or port weld separation.
Immediately stop using the device if leaks are detected.
The port weld in the ChemosafeLock Connecter may separate or break during use, potentially causing leaks that could lead to medication exposure or contamination.
The affected model is KL-FNU3 with specific lot numbers: 14399518, 14399521, 14406408, 14399520, 14406410, 14406411.
The product was distributed in Japan.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0364-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0364-2026 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.
