ICU Medical recalls ChemoLock Closed Vial Spikes with potential port weld leaks. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemoLock Closed Vial Spikes that may leak due to a port weld issue. This could lead to medication leaks during use, posing a risk to patient safety.
The port weld in the spike may separate or break during use, causing medication to leak. This leak could lead to contamination or incorrect dosing of medications, potentially harming patients.
Healthcare professionals using the ChemoLock Closed Vial Spikes for medication administration are most at risk. Patients receiving treatment with these spikes could be affected if the leak occurs.
Check for the model number CL-80S-5 and lot numbers 14395313, 143:93195, or 14396054. The product has a unique device identifier (UDI) starting with 10887709077116.
Discontinue use of the ChemoLock Closed Vial Spikes with the specified lot numbers and UDI to prevent potential leaks.
The recalled product is ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units with model REF: CL-80S-5.
Lot numbers 14395313, 14393195, and 14396054 are affected.
Check the unique device identifier (UDI) starting with 10887709077116 and the lot numbers listed above.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0348-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0348-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
