ICU Medical recalls 50 pouches of 9.5-inch smallbore trifuse sets with potential manufacturing defects causing improper sealing. Affected sets may not seal correctly with the spike, risking fluid leaks during 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 50 pouches of smallbore trifuse sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to fluid leaks during medical use, potentially causing harm to patients.
The sets may have a manufacturing defect on the internal surface of the NanoClave that prevents it from sealing properly with the spike. This could allow fluid to leak during use, potentially causing harm to patients.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatment with these sets could experience fluid leaks.
Check for the lot number 4558471 on the packaging. The product is a single-use sterile set with 3 MicroClave clear, NanoClave, and 3 check valves, sold in 50 pouches per case.
Verify the lot number 4558471 on the packaging to confirm if your set is affected.
The internal surface of the NanoClave may have a manufacturing defect that prevents proper sealing with the spike.
50 pouches per case.
The recall record does not specify a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0199-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0199-2021 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.
