ICU Medical recalls specific NanoClave sets due to potential manufacturing defects that may prevent proper sealing with the spike. Affected units include lot numbers 4584874 and 4565685.
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 have a manufacturing defect causing improper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The defect may prevent the NanoClave from forming a proper seal with the spike, potentially leading to improper fluid administration. This could cause complications during medical procedures if the seal fails.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatments via these sets could be affected if the seal fails.
Check for lot numbers 4584874 or 4565685 on the packaging. These sets are sold in pouches of 50 per case.
Look for lot numbers 4584874 or 4565685 on the packaging to identify affected units.
The recall states there is a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Check for lot numbers 4584874 or 4565685 on the packaging. These sets are sold in pouches of 50 per case.
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-0269-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0269-2021 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.
