ICU Medical recalls 50-pouch sets with potential seal defect in NanoClave spike. Affected units may not seal properly, risking improper fluid administration. 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 small medical tubing sets that may have a seal defect in the NanoClave spike. This could prevent proper fluid administration during medical procedures, potentially causing harm to patients.
The NanoClave spike may not seal properly with the internal surface due to a manufacturing defect. This could lead to improper fluid administration during medical procedures, potentially causing harm to patients.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could be affected if the seal fails.
Check for lot numbers 4572966 or 4557530 on the packaging. The product includes 50 pouches per case with a specific UDI code.
Look for lot numbers 4572966 or 4557530 on the packaging.
Reach out to ICU Medical for return instructions or alternative solutions.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check for lot numbers 4572966 or 4557530 on the packaging. The product includes 50 pouches per case.
The recall states a potential seal defect that could inhibit proper fluid administration, but does not specify a risk of serious injury.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0209-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0209-2021 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.
