ICU Medical recalls CL-80 ChemoLock Closed Vial Spikes due to potential port weld separation causing leaks. Affected units have UDI 1088770:14391976. 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 its CL-80 ChemoLock Closed Vial Spikes because the port weld might break during use, causing leaks. This could lead to medication exposure risks for patients. Affected units have a specific UDI and lot number.
The port weld in the spike may separate or break during use, leading to leaks of medication. This could expose healthcare workers and patients to potentially harmful substances. Leaks might cause contamination or incorrect dosing.
Healthcare professionals using ICU Medical ChemoLock Closed Vial Spikes for chemotherapy administration are most at risk. Patients receiving treatment through these spikes could be exposed to medication leaks.
Check for the product name 'ICU Medical ChemoLock Closed Vial Spike REF: CL-80' with UDI 10887709057125 and lot number 14391976. This recall applies to units sold with these specific identifiers.
Discard the recalled ChemoLock Closed Vial Spike to prevent leaks and potential exposure.
The recalled model is ICU Medical ChemoLock Closed Vial Spike REF: CL-80 with UDI 10887709057125 and lot number 14391976.
Check for the product name 'ICU Medical ChemoLock Closed Vial Spike REF: CL-80' with UDI 10887709057125 and lot number 14391976.
The recall does not mention a return process; discard the spike immediately to prevent leaks.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0346-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0346-2026 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.
