ICU Medical recalls 107" smallbore IV sets with potential seal defects in NanoClave connectors. Affected units may not seal properly with spikes, risking leaks. 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 a specific IV set that may have a seal defect in the NanoClave connector. This could prevent proper sealing with the spike, potentially causing leaks during use.
The internal surface of the NanoClave connector may have a manufacturing defect that prevents it from creating a proper seal with the spike. This could lead to leaks of fluids during administration, potentially causing patient discomfort or treatment complications.
Healthcare professionals using this IV set for patient care. Patients receiving IV treatments with this specific set are at risk if the seal fails.
Look for the product name: 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer. Check the UDI code: (01)10887709085005(17)250101(30)50(10)4572911. The product comes in 50 pouches per case.
Verify the product name and UDI code to confirm if your unit is affected.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave connector that may inhibit a proper seal with the spike.
Check for the product name: 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer. The UDI code (01)10887709085005(17)250101(30)50(10)4572911 indicates the affected lot.
The recall record does not specify a remedy, so contact ICU Medical directly 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-0198-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0198-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
