ICU Medical recalls 50 pouches of NanoClave sets with possible seal issues that could affect medical use. Affected units have specific UDI codes and 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 pouches of Nano:Clave sets that may have a manufacturing defect causing improper sealing. This could lead to medical complications during use if the seal fails.
The internal surface of the NanoClave may have a defect that prevents it from sealing properly with the spike. This could allow fluids to leak or cause contamination during medical procedures.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could face complications if the seal fails.
Check for the UDI code (01)10887709083346(17)250201(30)50(10)4718652 on the packaging. The affected units are sold in pouches with one set per pouch and 50 pouches per case.
Look for the UDI code (01)10887709083346(17)250201(30)50(10)4718652 on the packaging to identify affected units.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the spike.
Check for the UDI code (01)10887709083346(17)250201(30)50(10)4718652 on the packaging. Affected units are sold in pouches with one set per pouch and 50 pouches per case.
The recall record 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-0279-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0279-2021 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.
