ICU Medical recalls ChemoLock Vial Spikes (REF: CL-80S) 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 Vial Spikes (20mm REF: CL- 80S) because the port weld may break during use, leading to leaks. This could cause medication contamination or exposure to harmful substances.
The port weld in the vial spike can separate or break during use, which may cause medication leaks. This could lead to contamination of the medication or exposure to harmful substances for healthcare workers and patients.
Healthcare professionals using these vial spikes for chemotherapy administration are most at risk. Patients receiving treatments through these devices may also be affected if leaks occur.
Check for the product name 'ChemoLock Vial Spike, 20mm REF: CL-80S' on the device. Affected units have specific UDI numbers: 10887709069593 and lot numbers: 14379182, 14391979, 14395300, 14401254, 14380121.
Verify the product name and UDI/lot numbers to confirm if your device is affected.
The recall states the port weld may separate or break during use, potentially causing leaks. This could lead to medication contamination or exposure to harmful substances.
Check for the product name 'ChemoLock Vial Spike, 20mm REF: CL-80S' and verify the UDI number (10887709069593) and lot numbers (14379182, 14391979, 14395300, 14401254, 14380121).
The recall does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0347-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0347-2026 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.
