ICU Medical recalls specific NanoClave sets due to potential seal failure with spikes. Affected units may not seal properly, risking improper fluid administration. Contact for remedy details.
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 certain NanoClave sets that may not seal properly with the spike, potentially leading to improper fluid administration. This could affect patients receiving intravenous treatments.
The internal surface of the NanoClave in specific lots may have a manufacturing defect that prevents it from sealing correctly with the spike. This could lead to improper fluid administration during intravenous treatments.
Healthcare professionals using the recalled NanoClave sets for intravenous fluid administration are most at risk. Patients receiving IV treatments with these sets could be affected.
Check for the lot number 4557643 on the packaging. The product includes 50 pouches per case with a specific UDI code (01)10887709088354(17)250101(30)50(10)4557643.
Look for the lot number 4557643 on the packaging to identify affected units.
The internal surface of the NanoClave in specific lots may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check for the lot number 4557643 on the packaging. The product includes 50 pouches per case with the UDI code (01)10887709088354(17)250101(30)50(10)4557643.
The recall record does not specify a remedy, so contact ICU Medical directly for 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-0240-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0240-2021 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.
