ICU Medical recalls 112" burette sets with possible seal issues. Affected units may not seal properly with spikes, risking leaks. Contact for replacement.
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 112-inch burette sets that may have a manufacturing defect causing improper sealing with spikes. This could lead to leaks during medical use, potentially causing harm to patients.
The burette sets may have a defect in the internal surface of the NanoClave component. This defect can prevent a proper seal with the NanoClave spike, leading to potential leaks during medical procedures.
Healthcare professionals using the burette sets for intravenous fluid administration are most at risk. Patients receiving IV treatments with these sets could experience leaks or other complications.
Check for the lot number 4727501 on the product. The affected sets are 112 inches (284 cm) with 60 drops of 150ml capacity, sold in cases of 25 pouches.
Verify the lot number on the product is 4727501 to confirm if it's affected.
The recall is due to a potential manufacturing defect in the internal surface of the NanoClave that may inhibit a proper seal with the NanoClave spike.
The defect could cause improper sealing, potentially leading to leaks during medical procedures, which may harm patients.
Look for the lot number 4727501 on the product. The affected sets are 112 inches (284 cm) with 60 drops of 150ml capacity, sold in cases of 25 pouches.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0258-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0258-2021 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.
