ICU Medical recalls 15-drop primary sets with a potential seal defect in the NanoClave stopcock that may cause improper connections during medical use. Affected units have specific lot numbers and are sold in pouches.
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 15-drop primary sets that may have a manufacturing defect in the NanoClave stopcock, which could prevent a proper seal with the spike. This could lead to improper fluid administration during medical procedures.
The NanoClave stopcock's internal surface may have a manufacturing defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications.
Healthcare professionals using the 15-drop primary sets for intravenous fluid administration are most at risk. Patients receiving treatment with these sets could be affected if the seal fails.
Check for the lot number 4724881 on the packaging. The product is sold in 50 pouches per case and includes a unique device identifier (UDI) starting with (01)10887709070902.
Look for the lot number 4724881 on the packaging or the unique device identifier (UDI) starting with (01)10887709070902.
The internal surface of the NanoClave stopcock may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check for the lot number 4724881 on the packaging or the unique device identifier (UDI) starting with (01)10887709070902.
The recall does not specify a remedy, so contact ICU Medical directly 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-0218-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0218-2021 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.
