ICU Medical recalls 50 units of smallbore IV sets with potential manufacturing defect causing improper seal with NanoClave spike. Affected units have specific lot number 4557524.
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 IV sets that may have a manufacturing defect preventing proper sealing with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave in specific lots may not seal properly with the spike. This could allow fluid leakage or improper administration during medical procedures.
Healthcare professionals using these IV sets for patient care. Patients receiving IV treatments with affected sets may be at risk of improper fluid administration.
Check for lot number 4557524 on the packaging. The product is a single-use IV set with a 0.2 micron filter, clamp, and rotating Luer connector.
Look for lot number 4557524 on the packaging to confirm if your set is affected.
The product may have a manufacturing defect that could prevent proper sealing with the NanoClave spike, so it should not be used until the recall is addressed.
50 units of the smallbore IV sets with specific lot number 4557524 are being recalled.
Check the lot number on the packaging. If it is 4557524, contact ICU Medical 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-0203-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0203-2021 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.
