ICU Medical recalls Double ChemoLock Port Sy: CL-33 sets with potential leak risk from port weld separation. 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 Double ChemoLock Port Syringe Transfer Set model CL-33 due to a risk of port weld separation causing leaks during use. This could lead to medication exposure or contamination if the device breaks.
The port weld in the device may separate or break during use, potentially causing a leak of medication. This could lead to contamination or exposure to hazardous substances if the device fails.
Healthcare professionals using the CL-33 transfer sets for chemotherapy administration are most at risk. Patients receiving treatment through these devices may also be affected.
Check for the model number CL-33 on the device. Affected units have specific UDI numbers: 10840619061729 and lot numbers 14393155, 14400613, 14376051.
Look for the model number CL-33 on the device to confirm if it is affected.
Yes, the port weld may separate or break during use, potentially causing a leak of medication.
Check the model number and UDI/lot numbers to see if it is affected. If affected, contact ICU Medical for further instructions.
Affected units have the model number CL-33 and specific UDI: 10840619061729 with lot numbers 14393155, 14400613, or 14376051.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0342-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0342-2026 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.
