ICU Medical recalls 50 pouches of NanoClave Stopcocks 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 50 pouches of NanoClave Stopcocks that may not seal properly with spikes, which could lead to improper fluid administration during medical procedures. This defect affects specific lots and requires immediate attention to ensure patient safety.
The internal surface of the NanoClave stopcocks in specific lots may have a manufacturing defect that prevents a proper seal with the spike. This could lead to improper fluid administration during medical procedures, potentially causing patient harm.
Healthcare professionals using these stopcocks for medical procedures are most at risk. Patients receiving fluids through these devices could face complications if the seal fails.
Check for the lot number 4549131 on the packaging. The product is a single-use sterile device sold in 50 pouches per case with a unique identifier (UDI) starting with (01)10887709084435.
Look for the lot number 4549131 on the packaging to confirm if your unit is affected.
The internal surface of the NanoClave stopcocks in specific lots may have a manufacturing defect that inhibits a proper seal with the spike.
50 pouches per case, each containing one NanoClave stopcock unit.
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-0217-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0217-2021 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.
