ICU Medical recalls 18 cm IV sets with NanoClave manifold due to potential leaks or separation between 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 18 cm IV sets with NanoClave manifolds because they might leak or separate, causing safety risks during medical use. Patients and healthcare workers using these sets should stop using them immediately.
The NanoClave manifold can develop leaks or separate from the female luer during use, which could lead to improper fluid delivery or infection risks. This is a safety issue for medical procedures where precise connections are critical.
Healthcare professionals and patients using the recalled IV sets with NanoClave manifolds are most at risk. The specific lot numbers and expiration dates listed in the recall indicate which units are affected.
Check for the product name: 18 cm (7") PUR Smallbore Ext Set with 6-Port NanoClave Manifold. Affected units have lot numbers 3442842 or 3508246 and expiration dates of 05/01/2021 or 08/01/2022.
Verify the lot number and expiration date on the product label to confirm if it's affected.
If the product matches the recalled details, stop using it right away to prevent potential leaks or separation.
The recalled product is the 18 cm (7") PUR Smallbore Ext Set with 6-Port NanoClave Manifold, Check Valve, NanoClave, and Rotating Luer.
Check for lot numbers 3442842 or 3508246 with expiration dates of 05/01/2021 or 08/01/2022.
The recall does not mention a fix; the remedy is null, so affected units should be stopped from use immediately.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2803-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2803-2018 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.