ICU Medical recalls 50 pouches of NanoClave 4-Way Stopcock sets due to potential manufacturing defect that may prevent proper sealing with the spike. Affected units have specific lot numbers.
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 Nano:Clave 4-Way Stopcock sets because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot number 4605138 on the packaging. The product is a single-use sterile set sold in pouches of 50 units.
Look for the lot number 4605138 on the packaging to confirm if your set is affected.
ICU Medical recalls these sets due to a potential manufacturing defect that may prevent proper sealing with the spike.
The affected lot number is 4605138.
50 pouches of the NanoClave 4-Way Stopcock sets are being recalled.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0215-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0215-2021 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.
