ICU Medical recalls 1.5ml NanoClave sets with specific lot numbers due to potential manufacturing defect that may prevent proper sealing with the spike. Affected units include 50 pouches per case.
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 1.5ml NanoClave sets that may have a manufacturing defect causing improper sealing with the spike. This could lead to fluid leakage during medical procedures. Affected units have specific lot numbers and are sold in pouches of 50.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike. This could cause fluid leakage during medical procedures, potentially leading to complications for patients.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatment with the recalled sets could experience fluid leakage.
Check the lot numbers: 4565730, 4713953, 4730099, 4599979, 4589962, 4711191, or 4733727. The product is a single-use sterile device sold in pouches of 50.
Verify the lot number on the product to see if it matches the affected numbers: 4565730, 4713953, 4730099, 4599979, 4589962, 4711191, or 4733727.
ICU Medical recalls 1.5ml NanoClave sets with specific lot numbers that may have a manufacturing defect causing improper sealing with the spike.
50 pouches per case, with each pouch containing one unit.
Check the lot number on the product to see if it matches the affected numbers. If it does, stop using it and contact ICU Medical for further 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-0235-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0235-2021 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.
