ICU Medical recalls 50 pouches of 3-port NanoClave Manifold sets due to potential seal failure with spikes. Affected units have specific UDI codes. Stop using immediately to prevent infection risks.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
ICU Medical is recalling 50 pouches of 3-port NanoClave Manifold sets because a manufacturing defect might prevent proper sealing with the spike. This could lead to infection risks if the device isn't sealed correctly.
The internal surface of the NanoClave manifold may have a defect that prevents it from sealing properly with the spike. This could allow contaminants to enter the patient's bloodstream during fluid administration, causing infection.
Healthcare professionals using these medical devices for patient fluid administration. Patients receiving treatments through these sets are at risk of infection if the seal fails.
Check for the UDI code (01)10840:619062761(17)241201(30)50(10)4553703 on the packaging. The product is a 3-port NanoClave Manifold set sold in 50-pouch cases.
Immediately discard the affected NanoClave Manifold sets as they may not seal properly with the spike, risking infection.
The UDI code for the recalled units is (01)10840619062761(17)241201(30)50(10)4553703.
50 pouches of 3-port NanoClave Manifold sets are affected, with one unit per pouch.
A potential manufacturing defect on the internal surface of the NanoClave manifold may inhibit proper sealing with the spike, increasing infection risk.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0270-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0270-2021 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.
