ICU Medical recalls Clave Stopcock units with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the NanoClave spike, risking fluid leaks during medical procedures.
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 Clave Stopcock devices that may not seal properly with the NanoClave spike, potentially causing fluid leaks during medical procedures. This recall affects specific units with lot number 4727496.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from creating a proper seal with the NanoClave spike. This could lead to fluid leaks during medical procedures, potentially causing patient discomfort or complications.
Healthcare professionals using Clave Stopcock devices for administering fluids to patients are most at risk. Patients receiving treatments through these devices could experience fluid leaks if the seal fails.
Check for the lot number 4727496 on the Clave Stopcock device. The product comes in pouches with 1 unit per pouch and 50 pouches per case.
Look for the lot number 4727496 on the Clave Stopcock device to confirm if it is affected.
Lot number 4727496 is affected by this recall.
1 unit per pouch, with 50 pouches per case, totaling 50 units affected.
The affected units may not seal properly with the NanoClave spike, potentially causing fluid leaks during medical procedures.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0250-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0250-2021 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.
