ICU Medical recalls 25-pouch sets of NanoClave 3-Port Manifold with potential seal failure risk. Affected units may not seal properly with the spike, causing administration issues.
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 25-pouch sets of their NanoClave 3-Port Manifold due to a potential manufacturing defect that could prevent proper sealing with the spike. This might lead to improper fluid administration during medical procedures.
The defect may cause the NanoClave manifold to not seal properly with the spike, potentially leading to improper fluid administration during medical procedures. This could result in complications for patients receiving intravenous treatments.
Healthcare professionals using the NanoClave manifold for intravenous fluid administration are most at risk. Patients receiving treatments through this device could be affected if the seal fails.
Check for the model: 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. Affected units have lot numbers 4556714 or 4573639.
Look for the lot numbers 4556714 or 4573639 on the packaging or device.
The recall states there is a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
25 pouches per case, with specific lot numbers 4556714 and 4573639.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0234-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0234-2021 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.
