ICU Medical recalls 43cm IV sets with NanoClave manifold due to potential leaks or separation between components. 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 43 cm IV sets with NanoClave manifolds because they might leak or separate, which could cause problems during medical use. This affects specific units sold with certain lot numbers and expiration dates.
The NanoClave manifold might leak or separate from the female luer connector, potentially causing interruptions in IV treatment or contamination. This could lead to complications for patients receiving intravenous therapy.
Healthcare professionals using these IV sets in medical facilities are most at risk. Patients receiving IV treatments with the recalled sets could be affected if the sets malfunction.
Check for the item number 011-AM3011 and lot number 3408988 on the packaging. The expiration date is February 1, 2022.
Look for item number 011-AM3011 and lot number 3408988 on the packaging.
The recall is due to potential leaks or separation between the female luer and NanoClave manifold, which could interrupt IV treatment.
Check the item number and lot number on the packaging to see if it's affected. If it is, contact ICU Medical for further instructions.
The official recall notice does not specify a deadline for action.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2802-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2802-2018 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.
