ICU Medical recalls 60" Smallbore Trifuse Ext Sets with specific NanoClave lots due to potential seal failure risk. Affected units have unique UDI codes; contact for remedy.
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 60-inch Smallbore Trifuse Ext Sets with specific NanoClave filters because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The NanoClave filter's internal surface may have a defect that prevents it from sealing correctly with the spike. This could allow fluid to leak or not flow properly during medical procedures, potentially causing treatment errors.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could face complications if the seal fails.
Check for the UDI codes: (01)10887709083889(17)241201(30)50(10)4514845, (01)10887709083889(17)250101(30)50(10)4549102, or (01)10887709083889(17)250201(30)50(10)4730714. The product is a single-use intravenous set sold in 50-pouch cases.
Look for the specific UDI codes listed in the recall notice to confirm if your set is affected.
A potential manufacturing defect on the internal surface of the NanoClave filter may inhibit proper sealing with the spike, which could lead to improper fluid administration during medical procedures.
The recall notice does not specify a remedy; check the UDI codes to determine if your set is affected and contact ICU Medical for further instructions.
Check for the UDI codes: (01)10887709083889(17)241201(30)50(10)4514845, (01)10887709083889(17)250101(30)50(10)4549102, or (01)10887709083889(17)250201(30)50(10)4730714.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0206-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0206-2021 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.
