ICU Medical recalls specific NanoClave sets due to potential manufacturing defects that could prevent proper sealing with the spike. Affected units include certain lot numbers and sizes.
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 specific NanoClave sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper administration of fluids during medical procedures.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing correctly with the spike. This could allow fluids to leak or cause improper administration during medical procedures.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot number 4603841 on the packaging. The affected sets are 148 inches long, approximately 18.8 ml, with 15 drop sets and 2 claves per pouch, in sets of 25 pouches per case.
Look for the lot number 4603841 on the packaging to identify affected units.
The internal surface of the NanoClave may have a manufacturing defect that could prevent proper sealing with the spike.
Check for the lot number 4603841 on the packaging. Affected sets are 148 inches long, approximately 18.8 ml, with 15 drop sets and 2 claves per pouch, in sets of 25 pouches per case.
The recall record 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-0255-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0255-2021 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.
