ICU Medical recalls ChemoLock Bag Spike with Clave Additive Port REF: CL394: Port weld may separate during use, causing leaks. Affected units have UDI 10887709095295 and lot 14406773.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemoLock Bag Spikes with Clave Additive Port REF: CL3940 because the port weld might break during use, leading to leaks. This could cause medication to leak out of the device, potentially affecting patient safety.
The port weld in the ChemoLock Bag Spike may separate or break during use, which can cause medication to leak. This leak could lead to incorrect dosing or contamination of the patient's treatment.
Healthcare professionals using the ChemoLock Bag Spike with Clave Additive Port REF: CL3940 are most at risk. Patients receiving treatments through this device could be affected if the port weld breaks.
Check for the product name 'ChemoLock Bag Spike with Clave Additive Port' and the reference number REF: CL3940. Affected units have a Unique Device Identifier (UDI) of 10887709095295 and lot number 14406773.
Look for the reference number REF: CL3940 and UDI 10887709095295 on the device.
The recall states the port weld may separate or break during use, causing leaks. This could affect patient safety, so it's recommended to check if you have the affected model.
The recall does not specify a remedy. Check the product details to see if it matches the affected model and contact ICU Medical for further instructions.
Affected units have the reference number REF: CL3940, UDI 10887709095295, and lot number 14406773. Check your device for these identifiers.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0335-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0335-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
