ICU Medical recalls ChemoLock Vented Vial Spikes (REF: CL-70S) due to potential port weld separation causing leaks during use. Affected units have specific UDI and lot numbers.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemoLock Vented Vial Spikes (REF: CL- 70S) because the port weld might break during use, leading to leaks. This could cause medication to leak out of the vial, potentially affecting treatment safety.
The port weld in the vial spike may separate or break during use, causing medication to leak. This leak could lead to incorrect dosing or contamination of the medication.
Healthcare professionals using the ChemoLock Vial Spikes for medication administration are most at risk. Patients receiving treatments through these spikes could be affected if leaks occur.
Check for the product name 'ChemoLock Vented Vial Spike, 20mm' with reference number CL-70S. Units have a unique device identifier (UDI) starting with 10887709067155 and lot number 14379176.
Look for the reference number CL-70S and unique device identifier starting with 10887709067155 on the product.
The port weld may separate or break during use, potentially causing medication leaks.
Check for the reference number CL-70S and unique device identifier starting with 10887709067155 on the product.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0344-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0344-2026 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.
