ICU Medical recalls 50-pouch cases of 6-inch intravenous sets with a possible seal defect that could affect safe use. Affected units have specific lot numbers.
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-pouch cases of 6-inch intravenous sets that may have a seal defect preventing proper connection to the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave set may have a manufacturing defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures if the seal fails.
Healthcare professionals using these intravenous sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could be affected if the seal defect causes improper fluid delivery.
Check for lot numbers 45847: 4584753 or 4559022 on the packaging. The product is a single-use intravenous set sold in 50-pouch cases.
Look for lot numbers 4584753 or 4559022 on the packaging.
The internal surface of the NanoClave set may have a manufacturing defect that could prevent proper sealing with the spike.
Check for lot numbers 4584753 or 4559022 on the packaging. The product is a single-use intravenous set sold in 50-pouch cases.
The recall record does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0249-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0249-2021 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.
