ICU Medical recalls ChemosafeLock Bag Spikes with serial numbers 14399518-14406411 due to potential port weld separation causing leaks. Affected units distributed 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 Bag Spikes with specific serial numbers because the port weld might break during use, leading to leaks. This could cause medication to leak and potentially contaminate the patient's environment.
The port weld in the drug transfer device may separate or break during use, which could cause medication to leak. This leak might contaminate the patient's environment or lead to medication errors.
Healthcare professionals using the ChemosafeLock Bag Spikes in Japan are most at risk. Patients receiving medication through these devices could be affected if leaks occur.
Check the serial numbers on the ChemosafeLock Bag Spike: 14399518, 14399520, 14399521, 14406408, 14406410, 14406411. These units were distributed in Japan.
Look for the serial numbers 14399518, 14399520, 14399521, 14406408, 14406410, or 14406411 on the ChemosafeLock Bag Spike.
The port weld in the ChemosafeLock Bag Spike may separate or break during use, potentially causing medication leaks.
The recall record does not specify a remedy, so check the serial numbers and contact ICU Medical for further instructions.
This 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-0363-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0363-2026 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.
