ICU Medical recalls 25-pouch cases of 8.4ml 6:0 drop sets with potential seal issues. Affected units may not seal properly with spikes, risking leaks during IV use.
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 25-pouch cases of 8.4ml 60-drop sets that may not seal properly with the NanoClave spike. This could lead to leaks during IV administration, potentially causing patient harm.
The internal surface of the NanoClave in specific lots may not seal correctly with the spike. This could cause leaks during IV administration, potentially leading to patient harm.
Healthcare professionals using these IV sets for intravenous therapy are most at risk. Patients receiving IV treatments with affected sets could experience leaks.
Check for the lot number 4584862 on the packaging. The product is a single-use sterile IV set sold in 25-pouch cases.
Look for the lot number 4584862 on the packaging to confirm if your set is affected.
Reach out to ICU Medical directly for further guidance on safe use or replacement.
The recall indicates a potential seal issue in specific lots, so affected units may not seal properly. Use with caution.
Check for the lot number 4584862 on the packaging. This specific lot is affected.
Contact ICU Medical directly for guidance on safe use 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-0257-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0257-2021 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.
