ICU Medical recalls 10" Smallbore IV sets with NanoClave manifold due to potential leaks or separation between the female 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 10" Smallbore IV sets with NanoClave manifold because they may leak or separate, causing potential injury. This affects specific lot numbers and expiration dates.
The female luer connector may separate from the NanoClave manifold, leading to leaks or disconnection during IV administration. This could cause fluid loss or contamination in the patient's bloodstream.
Healthcare professionals using these IV sets for patient care are most at risk. Patients receiving IV treatments with the recalled sets could be affected.
Check for the 10" Smallbore Ext Set with 6-Port NanoClave Manifold (orange, red, blue, purple, yellow, green rings) and the NanoClave (light blue ring). Affected units have lot numbers 3423330 or 3476737 with expiration dates of 04/01/2022 or 06/01/2022.
Look for the 10" Smallbore Ext Set with 6-Port NanoClave Manifold and specific lot numbers (3423330 or 3476737) with expiration dates of 04/01/2022 or 06/01/2022.
The female luer connector may separate from the NanoClave manifold, leading to leaks or disconnection during IV administration.
Check for the specific lot numbers and expiration dates listed in the recall notice. If you have the affected units, contact ICU Medical for guidance.
Yes, separation could cause leaks or disconnection, potentially leading to fluid loss or contamination in the patient's bloodstream.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2815-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2815-2018 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.
