ICU Medical recalls 50 pouches of NanoClave Stopcock Manifolds with possible seal issues affecting patient fluid administration. Affected units may not seal properly with the spike, risking improper fluid delivery.
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 Stopcock Manifolds that may have a manufacturing defect causing improper sealing with the spike. This could lead to incorrect fluid administration during medical procedures.
The internal surface of the NanoClave Stopcock Manifold may have a manufacturing defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
Healthcare professionals using the NanoClave Stopcock Manifolds for patient fluid administration are most at risk. The recall affects specific lot numbers of the device.
Check for lot numbers 4493459 or 4536673 on the packaging. The device comes in 50 pouches per case with one unit per pouch.
Look for lot numbers 4493459 or 4536673 on the packaging.
The internal surface may have a manufacturing defect that prevents proper sealing with the spike, potentially causing improper fluid administration during medical procedures.
50 pouches per case, with one unit per pouch, affected by lot numbers 4493459 and 4536673.
Check the lot number on the packaging. If it matches 4493459 or 4536673, stop using it and contact ICU Medical 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-0213-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0213-2021 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.
