ICU Medical recalls ChemoLock Bag Spike REF: CL-10 due to potential port weld separation causing leaks. Affected units have UDI 1088770:14419330. Stop using immediately to prevent drug leaks.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemoLock Bag Spike REF: CL-10 because the port weld might break during use, causing drug leaks. This could lead to serious injury if the leak occurs during chemotherapy treatment.
The port weld that connects the drug transfer device might separate or break while in use. This could cause a leak of chemotherapy medication, potentially leading to serious injury or contamination.
Healthcare professionals using ChemoLock Bag Spike REF: CL-10 for chemotherapy treatments are most at risk. Patients receiving chemotherapy through this device could be affected if the spike leaks.
Check for the ChemoLock Bag Spike REF: CL-10 with UDI 10887709056968 and lot number 14419330. This product was sold by ICU Medical, Inc. for chemotherapy treatments.
Discard the ChemoLock Bag Spike REF: CL-10 if it has UDI 10887709056968 and lot number 14419330 to prevent leaks.
No, this product is not safe to use as it may cause leaks due to a potential port weld separation.
Discard the ChemoLock Bag Spike REF: CL-10 with UDI 10887709056968 and lot number 14419330 immediately to prevent leaks.
Check for the ChemoLock Bag Spike REF: CL-10 with UDI 10887709056968 and lot number 14419330. This product was sold by ICU Medical, Inc. for chemotherapy treatments.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0341-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0341-2026 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.
