ICU Medical recalls 61 cm 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 61 cm IV sets with NanoClave manifolds because they might leak or separate, which could cause problems during medical use. This affects specific units with known lot numbers and expiration dates.
The NanoClave manifold might leak or separate from the female luer connector during use, potentially causing fluid loss or contamination. This could lead to medical complications if the IV system is not properly secured.
Healthcare professionals using these IV sets in medical facilities are most at risk. Patients receiving IV treatments with the recalled sets could face complications if the set separates or leaks.
Check for the product name '61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold' with specific lot numbers 3493948 or 3498107 and expiration date 07/01/2022.
Identify the lot number and expiration date on the product label to confirm if it's affected.
The recall is due to potential leaks or separation between the female luer and NanoClave manifold, which could cause medical complications.
Check the product label for the lot number and expiration date. If it matches the affected units, contact ICU Medical for guidance.
The recall record does not specify a fix or remedy, so affected units should be checked and contacted for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2811-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2811-2018 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.
