ICU Medical recalls 6" Smallbore Ext 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 6-inch smallbore IV sets with NanoClave manifolds because they may leak or separate, causing potential injury. This recall affects specific lot numbers and expiration dates of the product.
The NanoClave manifold may leak or separate from the female luer connector, potentially causing fluid leakage or disconnection during IV administration. This could lead to patient injury or treatment complications.
Healthcare professionals using IV sets for patient care are most at risk. Patients receiving IV treatments with these specific units could be affected.
Check for the product name '6" Smallbore Ext Set w/6-Port NanoClave Manifold' with specific lot numbers: 3414534, 3442461, or 3509517. Expiration dates are 02/01/2022, 05/01/2022, or 08/01/2022.
Identify the lot number and expiration date on the product label to confirm if it is affected.
The recall is due to the potential for leaks or separation between the female luer and NanoClave manifold, which could cause injury.
Lot numbers 3414534 (expiration 02/01/2022), 3442461 (expiration 05/01/2022), and 3509517 (expiration 08/01/2022).
No immediate stop is required; however, if you have the affected lot numbers, you should check the product for potential leaks or separation.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2816-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2816-2018 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.
