ICU Medical recalls 11" Smallbore Ext Sets with NanoClave manifold due to potential leaks or separation between components. 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 11" Smallbore Ext Sets with NanoClave manifold because they might leak or separate, which could cause problems during medical use. This affects specific batches sold with certain expiration dates.
The device may develop leaks or separate between the female luer and NanoClave manifold during use. This could lead to improper fluid delivery or other complications in medical procedures.
Healthcare professionals using these IV sets in medical settings are most at risk. Patients receiving treatment with the recalled sets could be affected if the device fails.
Check for lot numbers 3379607 or 3436226 on the packaging. The expiration dates are December 1, 2021, or April 1, 2022, respectively.
Look for lot numbers 3379607 or 3436226 on the packaging of the IV set.
Reach out to ICU Medical directly for specific instructions on how to handle the recalled items.
The recall is due to the potential for leaks or separation between the female luer and NanoClave manifold, which could affect medical use.
Check the lot number and expiration date on the packaging. If it matches the recalled numbers, contact ICU Medical for instructions.
The recall states potential leaks or separation, but does not specify a risk of serious injury. The hazard level is use caution.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2814-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2814-2018 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.
