ICU Medical recalls 25-pouch sets of NanoClave 3-Port Manifolds with specific lot numbers due to a potential manufacturing defect that may prevent proper sealing with the spike.
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 NanoClave 3-Port Manifolds that have specific lot numbers. The defect could prevent the device from sealing properly with the spike, which might lead to improper fluid administration during medical procedures.
The manufacturing defect on the internal surface of the NanoClave may prevent it from creating a proper seal with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications for patients.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could face complications if the seal fails.
Check the lot numbers on the packaging: 4475764 or 4720644. The product is a single-use sterile device sold in 25-pouch cases.
Look for lot numbers 4475764 or 4720644 on the packaging.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike.
Check the lot numbers on the packaging: 4475764 or 4720644. The product is sold in 25-pouch cases.
No, the recall does not require immediate discontinuation. Check the lot numbers to determine if your product is affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0226-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0226-2021 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.
