ICU Medical recalls 50-pouch cases of smallbore IV sets with potential seal defects in the NanoClave connector that could cause improper administration. Affected units have specific UDI codes and lot number 45727: 4572784.
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 IV sets that may have a seal defect in the NanoClave connector, which could lead to improper fluid administration. This recall affects specific lots of the product that were sold with a particular UDI code and lot number.
The NanoClave connector's internal surface may have a manufacturing defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications for patients.
Patients receiving IV treatments using this specific smallbore IV set are most at risk. Healthcare facilities that use this product for medical administration may also be affected.
Check for the UDI code (01)10887709075334(17)250101(30)50(10)4572784 on the packaging. The affected product has a specific lot number: 4572784.
Look for the UDI code (01)10887709075334(17)250101(30)50(10)4572784 and lot number 4572784 on the packaging.
The internal surface of the NanoClave connector may have a manufacturing defect that inhibits a proper seal with the spike.
Check for the UDI code (01)10887709075334(17)250101(30)50(10)4572784 and lot number 4572784 on the packaging.
The recall record does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0202-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0202-2021 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.
