ICU Medical recalls 25 pouches of NanoClave Stopcocks with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the spike, risking improper fluid administration.
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 pouches of NanoClave Stopcocks with specific lot numbers because a manufacturing defect might prevent the device from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave stopcock has a potential manufacturing defect that could prevent it from sealing properly with the spike. This might cause improper fluid administration during medical procedures, though the risk is not described as causing serious injury.
Healthcare professionals using these stopcocks for intravenous fluid administration are most at risk. Patients receiving IV treatments with affected units may experience improper fluid delivery.
Check for lot numbers 4573460, 4589956, or 4711185 on the packaging. The product is a single-use sterile device sold in 25 pouches per case.
Verify the lot numbers on the packaging: 4573460, 4589956, or 4711185.
The internal surface may have a manufacturing defect that could inhibit a proper seal with the NanoClave spike.
25 pouches per case with specific lot numbers: 4573460, 4589956, and 4711185.
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-0232-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0232-2021 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.
