ICU Medical recalls 50-pouch NanoClave sets with potential manufacturing defect causing improper seal. Affected units may not seal correctly with spikes, risking contamination. Stop using immediately.
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-pouch NanoClave sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to contamination if the set doesn't seal correctly during use.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike. If the seal fails, the set could become contaminated, potentially exposing patients to harmful substances during intravenous fluid administration.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving fluids through these sets could be exposed to contamination if the seal fails.
Look for the product name 'NanoClave Clear 6-PORT' with 50 pouches per case. The lot number 4723226 is associated with the affected units. The unique device identifier (UDI) starts with (01)10887709121703.
Discard the affected sets if you have them, as they may not seal properly with the spike.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the spike.
Check for the lot number 4723226 or the unique device identifier (UDI) starting with (01)10887709121703.
The recall record does not specify a return process or replacement options.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0243-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0243-2021 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.
