ICU Medical recalls ChemoLock Port w/Spiros Red Cap REF: CL-35 due to potential port weld separation causing leaks. Affected units distributed in Canada.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemoLock Port w/Spi:ros Red Cap REF: CL-35 devices because the port weld may separate or break during use, potentially causing leaks. This could lead to medication exposure or contamination risks for patients.
The port weld in the drug transfer device can separate or break during use, which may cause leaks. This could lead to medication exposure or contamination risks for patients.
Healthcare professionals using the ChemoLock Port w/Spiros Red Cap REF: CL-35 in Canada are most at risk. Patients receiving chemotherapy through this device may also be affected.
Check for the ChemoLock Port w/Spiros Red Cap with REF: CL-35. The lot numbers 14407070, 14384996, and 14391949 are associated with this recall. The product was distributed in Canada.
Inspect the port weld for signs of separation or leakage after use.
Reach out to ICU Medical for guidance on next steps if leaks are detected.
The recall indicates a potential risk of port weld separation causing leaks, so it is not safe to use without checking for issues.
Look for the ChemoLock Port w/Spiros Red Cap with REF: CL-35 and lot numbers 14407070, 14384996, or 14391949.
Check for leaks and contact ICU Medical for guidance if leaks are detected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0357-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0357-2026 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.
