ICU Medical recalls 123-inch 10-drop sets with specific lot numbers due to potential seal failure in the NanoClave component, which may cause improper fluid administration. Affected units include lot numbers 4536733 and 4573641.
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 123-inch 10-drop sets with specific lot numbers because a manufacturing defect might prevent the NanoClave from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
The NanoClave component has a potential manufacturing defect on its internal surface that may prevent it from sealing correctly with the spike. This could lead to improper fluid administration if the seal fails during use, potentially causing complications in medical procedures.
Healthcare professionals using the 123-inch 10-drop sets with lot numbers 4536733 or 4573641 are most at risk. Patients receiving these sets during medical procedures may be affected if the seal fails.
Check the lot numbers on the packaging: 4536733 or 4573641. The product is a 123-inch (312cm) approximately 16.1 ml, 10-drop set with 3 MicroClave and 3-Port NanoClave components.
Look for lot numbers 4536733 or 4573641 on the packaging.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check the lot numbers on the packaging: 4536733 or 4573641. The product is a 123-inch (312cm) approximately 16.1 ml, 10-drop set with 3 MicroClave and 3-Port NanoClave components.
The recall 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-0222-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0222-2021 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.
