ICU Medical recalls 50 units of NanoClave sets with potential manufacturing defect causing improper seal with spike. Affected units have specific lot number 4603496. Consumers should contact manufacturer 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 units of NanoClave sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike. This could cause improper fluid administration during medical procedures.
Healthcare professionals using these sets for medical procedures. Patients receiving treatments through these sets are at risk if the seal fails.
Check for lot number 4603496 on the packaging. The product includes 50 units per case with specific dimensions and components.
Look for lot number 4603496 on the packaging to identify affected units.
The internal surface of the NanoClave may have a manufacturing defect that inhibits proper sealing with the spike.
50 units per case with lot number 4603496.
Contact ICU Medical for details on the specific remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0246-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0246-2021 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.
