ICU Medical recalls 114" burette sets with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the NanoClave 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 114-inch burette 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 defect may cause the NanoClave to not seal correctly with the spike, leading to improper fluid administration. This could result in incorrect dosing or fluid leakage during medical procedures.
Healthcare professionals using the burette sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check the lot numbers: 4476428 or 4712888. The product includes a 114-inch burette set with specific components like the 3-Port NanoClave Manifold and check valves.
Verify the lot numbers on the product: 4476428 or 4712888.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check the lot numbers: 4476428 or 4712888. The product includes a 114-inch burette set with specific components like the 3-Port NanoClave Manifold and check valves.
The recall does not specify a remedy, so contact ICU Medical directly for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0230-2021 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.
