ICU Medical recalls smallbore pressure infusion sets with potential manufacturing defects in NanoClave components that may prevent proper sealing with spikes. Affected units include specific lot numbers and models sold in 2023.
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 smallbore pressure infusion sets that may have a manufacturing defect in the NanoClave component. This defect could prevent the set from sealing properly with the spike, potentially causing fluid leaks during medical use.
The NanoClave component may have a manufacturing defect that prevents it from creating a proper seal with the spike. This could lead to fluid leaks during medical procedures, potentially causing complications for patients.
Healthcare professionals using the recalled smallbore pressure infusion sets for medical fluid delivery are most at risk. Patients receiving treatments through these sets could experience fluid leaks if the seal fails.
Check for the lot number 4603265 on the packaging. The product includes a 9.5" (24 cm) smallbore pressure infusion set with two NanoClaves and a T-connector. These sets were sold in 2023 in pouches of 50 units.
Look for the lot number 4603265 on the packaging to identify affected units.
The NanoClave component may have a manufacturing defect that prevents it from creating a proper seal with the spike.
Check for the lot number 4603265 on the packaging. The product includes a 9.5" (24 cm) smallbore pressure infusion set with two NanoClaves and a T-connector.
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-0192-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0192-2021 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.
