ICU Medical recalls 24 pouches of 3-Port NanoClave Manifolds (Lot 4537328) due to potential seal failure with spikes. Affected units may not seal properly, risking infection during medical use.
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 24 pouches of 3-Port NanoClave Manifolds (Lot 4537328) because a manufacturing defect might prevent proper sealing with the spike. This could lead to infection if the device isn't used correctly.
The device has a potential manufacturing defect on its internal surface that may prevent it from sealing properly with the NanoClave spike. If the seal fails, it could allow contaminants to enter the patient's bloodstream, increasing infection risk.
Healthcare professionals using the device for medical fluid administration. Patients receiving treatments through this device are at risk if the seal fails.
Check for the lot number 4537328 on the packaging. The product is a single-use sterile device sold in 24 pouches per case.
Look for the lot number 4537328 on the packaging to confirm if your device is affected.
The device may have a manufacturing defect that could prevent proper sealing with the spike, so it is not safe to use as recalled.
24 pouches of the 3-Port NanoClave Manifold (Lot 4537328).
Check the lot number on the packaging. If it's 4537328, contact ICU Medical for instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0229-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0229-2021 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.
