ICU Medical recalls 20mm ChemoLock Vial Spikes due to potential port weld separation causing leaks. Affected units distributed in France with specific lot numbers.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling their ChemoLock Vial Spikes because the port weld might break during use, causing drug leaks. This could lead to contamination or improper medication delivery if the spike leaks.
The port weld that connects the spike to the vial may separate or break while in use. This can cause medication to leak out of the system, potentially leading to contamination or incorrect dosing.
Healthcare professionals using the ChemoLock Vial Spikes for medication administration in hospitals or clinics. Patients receiving IV treatments with these spikes are at risk if leaks occur.
Check for the ChemoLock Vial Spike with model REF: 011-CL-70S-20. Units distributed in France with lot number 14401659 are affected.
Inspect the spike for any signs of leaking or damaged port welds before use.
Reach out to ICU Medical for guidance on whether the spike needs replacement or repair.
The recall is for the spike itself, not the medication. If the spike leaks, it could affect medication delivery, but this is a potential risk with the specific model.
Look for the model REF: 011-CL-70S-20 and lot number 14401659, which were distributed in France.
The recall does not require immediate stoppage; healthcare professionals should check for leaks and contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0354-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0354-2026 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.
