ICU Medical recalls 21" Ext Set w/ChemoLock Port (REF: CL3360) due to potential port leaks from weld separation 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 its 21-inch extension set with ChemoLock Port because the drug transfer device's weld may separate or break, causing leaks. This could lead to medication exposure or contamination risks for patients. Affected units have specific UDI and lot numbers.
The port weld in the drug transfer device may separate or break during use, potentially causing medication leaks. This could lead to contamination of the patient's environment or exposure to hazardous drugs.
Healthcare professionals using the ICU Medical 21" Ext Set w/ChemoLock Port for chemotherapy administration are most at risk. Patients receiving treatment through this device could be exposed to medication leaks.
Check for the product name 'ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector' with reference number CL3360. Affected units have UDI:10887709071398 and lot numbers 14397348 or 14377757.
Identify the product by checking the reference number CL3360 and UDI:10887709071398 with lot numbers 14397348 or 14377757.
The recall states the port weld may separate or break during use, potentially causing leaks. Affected units should not be used until the remedy is applied.
The recall does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
Check for the reference number CL3360 and UDI:10887709071398 with lot numbers 14397348 or 14377757.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0351-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0351-2026 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.
