ICU Medical recalls 10" Smallbore 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 10" Smallbore IV sets with NanoClave manifolds because they may leak or separate, causing potential injury. This recall affects specific lot numbers and expiration dates.
The NanoClave manifold may leak or separate from the female luer connector, which could lead to fluid loss or contamination. This risk is particularly concerning during IV treatments where precise connections are critical.
Healthcare professionals using IV sets for patient care are most at risk. Patients receiving IV treatments with these sets could experience complications if the set separates or leaks.
Check for the 10" Smallbore Ext Set with 6-Port NanoClave Manifold (orange, red, blue, purple, yellow rings). Affected units have specific lot numbers: 3373756, 3423328, or 3446319, with expiration dates up to 05/01/2022.
Identify the lot number and expiration date on the product label to confirm if it is affected.
Reach out to ICU Medical directly for guidance on next steps if you have an affected unit.
The recall is due to the potential for leaks or separation between the female luer and NanoClave manifold, which could cause injury during IV treatments.
Affected models include the 10" Smallbore Ext Set with 6-Port NanoClave Manifold (orange, red, blue, purple, yellow rings), with lot numbers 3373756, 3423328, or 3446319.
Check the lot number on the product label; affected units have specific lot numbers: 3373756, 3423328, or 3446319, with expiration dates up to 05/01/2022.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2812-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2812-2018 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.
