ICU Medical recalls 50 units of smallbore IV sets with potential seal defects that could cause improper connections. Affected units have specific UDI codes and lot numbers.
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 causing improper seals. This could lead to incorrect 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 treatments through these sets are at risk if the seal fails.
Look for the UDI code (01)10887709080703(17)250101(30)50(10)4603290 on the packaging. The product includes a 0.2 micron filter and is sold in 50 pouches per case.
Verify the UDI code on the packaging to confirm if your set is affected.
The internal surface of the NanoClave in specific lots may not seal properly with the spike, potentially causing fluid leakage or improper administration.
50 units per case, with specific UDI and lot numbers.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0205-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0205-2021 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.
