ICU Medical recalls 50 pouches of 7" smallbore ext sets with possible seal issues on NanoClave components. Affected units may not seal properly with spikes, risking fluid leaks during medical use.
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 pouches of smallbore extension sets that may have a manufacturing defect causing the NanoClave component to fail sealing with the spike. This could lead to fluid leaks during medical procedures if the set is used.
The NanoClave component inside specific lots may not seal properly with the spike, potentially allowing fluid to leak during medical procedures. This defect arises from a manufacturing issue with the internal surface of the NanoClave.
Healthcare professionals using the recalled smallbore extension sets for medical fluid administration are most at risk. Patients receiving treatments through these sets could experience fluid leaks if the seal fails.
Check for the UDI codes (01)10887709065069(17)250101(30)50(10)4590843 or (01)10887709065069(17)250201(30)50(10)4733564 on the packaging. The product is a single-use sterile set sold in 50 pouches per case.
Verify the UDI codes on the packaging to confirm if your set is affected.
The internal surface of the NanoClave component may not seal properly with the spike, potentially causing fluid leaks during medical use.
50 pouches per case, with specific UDI codes: (01)10887709065069(17)250101(30)50(10)4590843 and (01)10887709065069(17)250201(30)50(10)4733564.
No immediate stop is required; check the UDI codes to confirm if your set is affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0194-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0194-2021 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.
