ICU Medical recalls small bore pressure infusion sets with potential manufacturing defects that may prevent proper sealing with the NanoClave 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 small bore pressure infusion sets that may not seal properly with the NanoClave spike due to a manufacturing defect. This could lead to improper fluid delivery during medical procedures.
The internal surface of the NanoClave in specific lots may not create a proper seal with the NanoClave spike. This could allow fluid leakage during medical procedures, potentially causing improper treatment delivery.
Healthcare professionals using these sets for medical fluid delivery. Patients receiving treatments through these sets are at risk if the seal fails.
Look for the purple clamp and rotating Luer on the set. Check the lot numbers: 4558455, 4537168, or 4493389. These sets were sold in pouches with specific UDI codes.
Verify the lot numbers on the set: 4558455, 4537168, or 4493389.
The internal surface of the NanoClave in specific lots may inhibit a proper seal with the NanoClave spike, potentially causing fluid leakage during medical procedures.
Check the lot numbers: 4558455, 4537168, or 4493389. The sets have a purple clamp and rotating Luer.
No, but you should check the lot numbers to confirm if your set is affected. If it is, you may need to contact ICU Medical for a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0193-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0193-2021 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.
