ICU Medical recalls 50 pouches of 0.75ml 6-Port NanoClave Manifolds due to potential seal failure with spikes. Affected units may not seal properly, risking infection during medical fluid administration.
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 their 0.75ml 6-:Port NanoClave Manifolds because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper fluid administration and infection risks for patients.
The internal surface of the NanoClave manifold may have a manufacturing defect that prevents it from sealing correctly with the spike. This could allow fluid to leak or not be delivered properly, increasing infection risk during medical procedures.
Healthcare facilities using these specific NanoClave sets for medical fluid administration are affected. Patients receiving treatments through these devices face the highest risk of infection if the seal fails.
Check for the Glow, Red, Blue, Purple, or Yellow rings on the NanoClave manifold. The product has a unique identifier (UDI) starting with (01)10840619083929(17)241201(30)50(10)4496182. The affected lot number is 4496182.
Verify the rings color and UDI code to confirm if your unit is affected.
A potential manufacturing defect on the internal surface of the NanoClave may inhibit proper sealing with the spike, which could lead to improper fluid administration and infection risks.
50 pouches per case, with the specific lot number 4496182.
The recall record does not specify a remedy or action steps beyond checking product details to confirm if affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0272-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0272-2021 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.
