ICU Medical recalls 7-inch 1.2ml ext sets with 6-port NanoClave manifold due to potential seal failure risk in specific lots. Affected units may not seal properly with the spike, risking improper 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 7-inch 1.2ml extension sets with 6-port NanoClave manifolds because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave manifold in specific lots may have a manufacturing defect that prevents it from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot numbers: 4548270, 4558614, 4733732, or 4493665. The product is a single-use sterile device sold in pouches of 50 units per case.
Look for the lot numbers 4548270, 4558614, 4733732, or 4493665 on the packaging.
The internal surface of the NanoClave manifold in specific lots may have a manufacturing defect that prevents proper sealing with the spike.
Check for the lot numbers 4548270, 4558614, 4733732, or 4493665 on the packaging. The product is a single-use sterile device sold in pouches of 50 units per case.
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-0236-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0236-2021 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.
