ICU Medical recalls 50 pouches of NanoClave sets with lot number 4726780 due to a potential manufacturing defect that may prevent proper sealing with the spike. This could lead to improper administration of fluids during medical procedures.
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 NanoClave sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper fluid administration during medical procedures if the seal fails.
The potential manufacturing defect on the internal surface of the NanoClave may prevent it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures if the seal fails.
Healthcare professionals using the NanoClave sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot number 4726780 on the packaging. The product is a single-use sterile intravenous administration set sold in 50 pouches per case.
Look for the lot number 4726780 on the packaging to identify affected units.
The recall states there is a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the NanoClave spike.
50 pouches per case with lot number 4726780 are affected.
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-0251-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0251-2021 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.
