ICU Medical recalls 50 units of smallbore ext sets with potential seal issues on NanoClave components. Affected units may not seal properly with spikes, risking infection. Consumers should contact for details.
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 smallbore extension sets that may have a manufacturing defect causing the NanoClave component to fail sealing with spikes. This could lead to infection risks during medical use.
The NanoClave component may not seal properly with the spike, potentially allowing contaminants to enter the patient's bloodstream. This defect occurs due to a manufacturing issue in specific lots.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could face infection if the seal fails.
Check for the lot numbers 4718521 or 4735100 on the packaging. These sets are sold in 50-pouch cases with a unique identifier code.
Look for lot numbers 4718521 or 4735100 on the packaging to identify affected units.
The NanoClave component may not seal properly with the spike, potentially allowing contaminants to enter the patient's bloodstream.
50 units per case, with lot numbers 4718521 and 4735100.
The recall indicates a potential seal failure risk, but no immediate stop-use instruction is provided. Check lot numbers first.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0265-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0265-2021 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.
