ICU Medical recalls 3-Port NanoClave Manifolds with a potential manufacturing defect that may inhibit proper sealing with the spike. Affected units include specific lot numbers from 4556715 to 4720392.
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 3-Port NanoClave Manifolds with a check valve that may have a manufacturing defect causing improper sealing with the spike. This could lead to fluid leaks during medical procedures, posing a risk of infection or other complications.
The device may have a manufacturing defect on the internal surface that prevents it from sealing properly with the spike. This could cause fluid leaks during medical procedures, potentially leading to infections or other complications.
Healthcare professionals using the 3-Port NanoClave Manifold for intravenous fluid administration are most at risk. Patients receiving treatments through this device could face potential complications if the seal fails.
Check for lot numbers 4556715, 4579939, 4592179, 4610925, 4547212, 4712946, or 4720392 on the packaging. The device is sold in pouches with 50 units per case.
Look for lot numbers 4556715, 4579939, 4592179, 4610925, 4547212, 4712946, or 4720392 on the packaging.
The recall states a potential manufacturing defect on the internal surface that may inhibit a proper seal with the spike.
1 unit per pouch, with 50 pouches per case, totaling 7 specific lot numbers.
The recall record shows no remedy is specified.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0224-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0224-2021 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.
