ICU Medical recalls 28cm 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 28 cm IV sets with NanoClave manifolds because they might leak or separate, causing safety risks during medical use. This affects specific batches sold with certain expiration dates.
The NanoClave manifold may leak or separate from the female luer connector during use, potentially causing fluid loss or incorrect medication delivery. This could lead to serious medical complications if the set is used without proper connection.
Healthcare professionals using these IV sets in medical facilities are most at risk. Patients receiving IV treatments with the recalled sets could face complications.
Check for the 28 cm (11") PUR Bifuse Ext Set with 6-Port NanoClave Manifold. Affected units have lot numbers 3380551 or 3493462 and expiration dates of 12/01/2021 or 07/01/2022.
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 product is the 28 cm (11") PUR Bifuse Ext Set with 6-Port NanoClave Manifold, Check Valve, 2 NanoClave, and Rotating Luer. Item Number 011-AM6116.
Lot numbers 3380551 and 3493462 are affected, with expiration dates of 12/01/2021 and 07/01/2022 respectively.
The recall does not require immediate discontinuation; however, you should check for leaks or separation before use.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2804-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2804-2018 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.
