ICU Medical recalls 50 pouches of NanoClave check valves due to potential manufacturing defects that may prevent proper sealing with the spike. Affected units have specific 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 NanoClave check valves that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper administration of fluids during medical procedures.
The check valves may not seal properly with the spike due to a manufacturing defect on the internal surface. This could lead to improper fluid administration during medical procedures.
Healthcare professionals using the NanoClave check valves for intravenous fluid administration are most at risk. Patients receiving treatments with these devices may be affected if the seal fails.
Check for lot numbers 4572779 or 4548202 on the packaging. The product is a single-use sterile device sold in 50 pouches per case.
Look for lot numbers 4572779 or 4548202 on the packaging to identify affected units.
The internal surface may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
50 pouches per case with specific lot numbers 4572779 and 4548202.
The recall record does not specify a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0200-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0200-2021 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.
