ICU Medical recalls 50-pouch sets of smallbore IV extension sets with a potential seal defect in specific lots that could affect safe use during medical procedures.
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 a specific type of IV tubing set due to a possible manufacturing defect that might prevent proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave component in specific lots may not seal properly with the spike. This could allow fluid leakage or improper administration during medical procedures.
Healthcare professionals using the recalled IV sets for patient care are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot numbers 4605103 or 4733543 on the packaging. The product is a single-use IV set sold in 50-pouch cases with a unique identifier code.
Look for lot numbers 4605103 or 4733543 on the packaging to identify affected units.
The internal surface of the NanoClave component in specific lots may not seal properly with the spike, potentially causing fluid leakage or improper administration.
Check for lot numbers 4605103 or 4733543 on the packaging. The product is a single-use IV set sold in 50-pouch cases.
The recall record does not specify a remedy, so users should check the lot numbers and contact ICU Medical for further 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-0184-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0184-2021 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.
