ICU Medical recalls 50 pouches of NanoClave stopcocks with possible seal issues that could affect patient fluid administration. Affected units have specific lot numbers and require immediate action.
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 NanoCl:ave stopcocks that may not seal properly with the spike, potentially causing fluid administration issues. This could affect patient safety during medical procedures.
The internal surface of the stopcock may have a manufacturing defect that prevents it from sealing correctly with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
Healthcare professionals using the NanoClave stopcocks for patient fluid administration are most at risk. Patients receiving treatments through these devices could be affected if the seal fails.
Check for lot numbers 4537253 or 4557545 on the packaging. The product comes in 50 pouches per case with a specific UDI code format.
Look for lot numbers 4537253 or 4557545 on the packaging to identify affected units.
Reach out to ICU Medical for further instructions on handling the recalled product.
The internal surface may have a manufacturing defect that prevents proper sealing with the NanoClave spike, potentially causing fluid administration issues.
50 pouches per case with lot numbers 4537253 and 4557545.
The recall requires checking the lot number and contacting the manufacturer, but there is no immediate stop-use instruction.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0220-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0220-2021 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.
