ICU Medical recalls ChemoLock Close Vial Spike REF CL-:80 due to incorrect packaging and labeling. This may cause confusion in healthcare settings. Affected units have specific lot numbers and model details.
Due to finished goods incorrectly packaged and labeled.
ICU Medical is recalling ChemoLock Close Vial Spike REF CL-80 because it was incorrectly packaged and labeled. This could lead to confusion in healthcare settings, potentially affecting proper use of the device.
The device was incorrectly packaged and labeled, which could lead to confusion in healthcare settings. This might result in improper use or misidentification of the device, but does not pose a direct safety risk like injury or fire.
Healthcare professionals using the ChemoLock Close Vial Spike REF CL-80 device are most at risk. Patients and staff handling the device may be affected if the labeling causes confusion.
Check for the model number CL-80 on the device. Affected units have the lot number 13959938 and UDI code (01)10887709057125(17)290401(30)50(10)13959938.
Look for the model number CL-80 and lot number 13959938 on the device.
The ChemoLock Close Vial Spike REF CL-80 was recalled due to incorrect packaging and labeling.
Check the device label for the model number CL-80 and lot number 13959938. If you have the affected model, contact ICU Medical for further instructions.
The recall is due to incorrect packaging and labeling, not a direct safety hazard. There is no risk of injury from the device itself.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0652-2025 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0652-2025 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.
