ICU Medical recalls 40 cm IV sets with NanoClave manifold due to potential leaks or separation between luer and manifold. Affected units have specific lot numbers and expiration dates.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
ICU Medical is recalling 40 cm IV sets with NanoClave manifolds because they might leak or separate, which could cause problems during medical use. This affects specific batches made before February 2022.
The NanoClave manifold may leak or separate from the female luer connector, potentially causing interruptions in IV fluid delivery or contamination. This could lead to treatment delays or infection risks during medical procedures.
Healthcare professionals using IV sets with this specific model are most at risk. Patients receiving IV treatments with these sets could be affected if the device fails.
Check for the item number 011-AM6126 on the packaging. Affected units have lot numbers 3409000 (expires 02/01/2022) or 3446970 (expires 05/01/2022).
Inspect the connection between the female luer and NanoClave manifold for signs of leakage or separation.
Reach out to ICU Medical directly for assistance with the recall process.
The item number is 011-AM6126.
Lot numbers 3409000 (expires 02/01/2022) and 3446970 (expires 05/01/2022).
The official recall does not mention a fix; users should check for leaks and contact the manufacturer.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2808-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2808-2018 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.
