ICU Medical recalls 6.5" Bag Spike w/ChemoLock Port Additive Port (REF: CL3955) due to potential port leak from broken welds. 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 their 6.5" Bag Spike with ChemoLock Port Additive Port (REF: CL3955) because the port weld might break during use, causing leaks. This could lead to medication errors or infections for patients using the device.
The port weld in the device may separate or break during use, which can cause medication leaks. This could lead to incorrect dosing or infections if the leaked medication contacts the patient's body.
Healthcare professionals using this device for chemotherapy or IV treatments are most at risk. Patients receiving care through this port could be affected if the device leaks.
Check for the product name '6.5" Bag Spike w/ChemoLock Port Additive Port' with reference number CL3955. Units have unique device identifiers (UDI) starting with 10887709071411 and lot numbers 14386086 or 14407433.
Look for the unique device identifier (UDI) starting with 10887709071411 and lot numbers 14386086 or 14407433.
The recall states the port weld may break during use, causing leaks. If you have the product, you should check the device ID and follow the action steps.
Check for the product name '6.5" Bag Spike w/ChemoLock Port Additive Port' with reference number CL3955. Units have unique device identifiers (UDI) starting with 10887709071411 and lot numbers 14386086 or 14407433.
The recall does not specify a remedy. Check the device ID 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-0353-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0353-2026 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.
