ICU Medical recalls specific NanoClave sets due to a potential manufacturing defect that may prevent proper sealing with the spike. Affected units have lot numbers 4515251 or 4537242.
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 certain NanoClave sets that may have a manufacturing defect causing improper sealing with the spike. This could lead to fluid leaks during medical administration, posing a risk of infection or other complications.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike. This could cause fluid leaks during IV administration, potentially leading to infections or other complications.
Healthcare professionals using the recalled NanoClave sets for intravenous fluid administration. Patients receiving IV treatments with these sets are at risk of potential leaks or infections.
Check for lot numbers 4515251 or 4537242 on the packaging. The product includes 25 pouches per case with specific dimensions and components.
Look for lot numbers 4515251 or 4537242 on the packaging to identify affected units.
The internal surface of the NanoClave may have a manufacturing defect that prevents proper sealing with the spike, potentially causing fluid leaks during IV administration.
Check for lot numbers 4515251 or 4537242 on the packaging. The product includes 25 pouches per case with specific dimensions and components.
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-0214-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0214-2021 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.
