ICU Medical recalls 20 cm IV sets with NanoClave manifold due to potential leaks or separation between the 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 certain 20 cm IV administration sets that may leak or separate between the female luer and NanoClave manifold. This could lead to improper fluid delivery to patients. Affected units have specific lot numbers and expiration dates.
The NanoClave manifold may leak or separate from the female luer connector during use, potentially causing improper fluid delivery to patients. This could lead to complications if the device fails during critical medical procedures.
Healthcare professionals using these IV sets for patient care are most at risk. Patients receiving fluids through these sets could be affected if the device fails.
Check for lot numbers 3326545 or 3459161 on the packaging. The expiration dates are September 1, 2021, and May 1, 2022, respectively. The product includes a 3-port NanoClave manifold.
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 recalled product is a 20 cm (8") PUR Smallbore Ext Set with 3-Port NanoClave Manifold, Check Valve, NanoClave, and Rotating Luer.
Lot numbers 3326545 (expiration 09/01/2021) and 3459161 (expiration 05/01/2022) are affected.
Check the lot number on the packaging; affected units have lot numbers 3326545 or 3459161 with specific expiration dates.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2797-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2797-2018 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.
