ICU Medical recalls ChemosafeLock Vial Adapters with specific model numbers due to potential port weld separation causing leaks during use. Affected units sold in Japan.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemosafeLock Vial Adapters with model numbers KL-VA001U3 through KL-VA321U3 because the port weld may separate or break, leading to leaks. This could cause medication contamination or exposure risks for healthcare users.
The port weld in the vial adapter may separate or break during use, potentially causing medication leaks. This could lead to contamination of the medication or exposure to hazardous substances.
Healthcare professionals using these vial adapters in medical settings are most at risk. Patients receiving treatments through these devices could be affected if leaks occur.
Check for model numbers KL-VA001U3, KL-VA002U3, KL-VA131U3, KL-VA201U3, KL-VA202U3, or KL-VA321U3 on the adapter. These units were distributed in Japan and sold with specific lot numbers listed in the recall notice.
Identify the model number on the adapter to confirm if it is in the recalled list: KL-VA001U3, KL-VA002U3, KL-VA131U3, KL-VA201U3, KL-VA202U3, or KL-VA321U3.
The recall indicates the port weld may separate or break during use, potentially causing leaks. Users should check if their adapter is in the recalled list before continuing use.
These adapters were distributed in Japan.
The recall does not specify a remedy, so users should check the model numbers and contact ICU Medical if they have a recalled adapter.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0365-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0365-2026 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.
