ICU Medical recalls ChemoLock 13mm Closed Vial Spikes REF: CL-82 due to potential port weld separation causing leaks. 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 ChemoLock 13mm Closed V:82 vial spikes because the port weld might break during use, leading to leaks. This could cause medication to spill or contaminate the patient's treatment area.
The port weld in the vial spike may separate or break during use, which could cause medication to leak. This leakage might contaminate the patient's treatment area or lead to improper medication delivery.
Healthcare professionals using the ChemoLock 13mm Closed Vial Spikes REF: CL-82 for administering chemotherapy. Patients receiving treatment through these spikes are at risk if leaks occur.
Check for the model number CL-82 on the vial spike. Affected units have a UDI of 10887709085692 and lot number 14407453.
Inspect the vial spike for signs of leakage or port weld damage before use.
Reach out to ICU Medical for guidance on whether your specific unit is affected.
The recall applies to healthcare professionals using the ChemoLock 13mm Closed Vial Spikes REF: CL-82. If you are administering chemotherapy, check if your vial spike matches the affected model.
Look for the model number CL-82 on the spike. Affected units have a UDI of 10887709085692 and lot number 14407453.
If you notice a leak, stop using the vial spike immediately and contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0349-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0349-2026 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.
