ICU Medical recalls 53" extension sets with specific NanoClave models due to potential seal failure when connecting to spikes. Affected units have lot number 4711366. Contact for return instructions.
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 53-inch extension sets with a specific NanoClave model because a manufacturing defect might prevent 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 creating a proper seal with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications.
Healthcare professionals using these extension sets for patient fluid administration. Patients receiving treatment with these sets are at risk if the seal fails during use.
Check for the lot number 4711366 on the packaging. The product includes a 53-inch extension set with a NanoClave model that has a specific internal surface defect.
Look for the lot number 4711366 on the packaging to confirm if your unit is affected.
The internal surface of the NanoClave may have a manufacturing defect that could inhibit a proper seal with the spike.
Check for the lot number 4711366 on the packaging. Affected units have this specific lot number.
The recall does not specify a remedy, so contact ICU Medical directly for instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0267-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0267-2021 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.
