ICU Medical recalls 50 units of smallbore IV sets with a potential manufacturing defect in the NanoClave clamp that may prevent proper sealing with the spike. 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 units of smallbore IV sets that may have a manufacturing defect in the NanoClave clamp. This defect could prevent the clamp from sealing properly with the spike, potentially causing leaks during medical use.
The NanoClave clamp may have a manufacturing defect on its internal surface that prevents it from creating a proper seal with the spike. This could lead to leaks of fluids during medical administration, which might cause patient discomfort or complications.
Healthcare professionals using these IV sets for patient care. Patients receiving IV treatments with the affected sets are at risk of potential leaks.
Check for the specific lot numbers: 4603254, 4630684, 4718516, 4514832, 4537159, 4558447, 4724820, or 4733554. The product is a single-use IV set with a NanoClave clamp and rotating Luer connector.
Verify if your unit has one of the specific lot numbers listed: 4603254, 4630684, 4718516, 4514832, 4537159, 4558447, 4724820, or 4733554.
The recall states there is a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the spike.
50 units of the smallbore IV sets are affected, each with a specific lot number.
Check if your unit has one of the listed lot numbers. If it does, stop using it and contact ICU Medical 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-0276-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0276-2021 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.
