ICU Medical recalls 50-pouch sets of Smallbore Trifuse Ext Sets with possible seal failure in specific lots. Affected units may not seal properly with the NanoClave spike, risking improper fluid administration.
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 type of medical IV set due to a potential manufacturing defect that could prevent proper sealing with the NanoClave spike. This defect might lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave connector in certain lots may have a manufacturing defect that prevents it from sealing correctly with the Nano:Clave spike. This could lead to improper fluid administration during medical procedures.
Patients receiving IV treatments using the recalled sets are affected. Healthcare providers using these specific medical devices are most at risk.
Check for the lot numbers 4475297 or 4711598 on the packaging. The product is a 5.5" (14 cm) Smallbore Trifuse Ext Set with 3 MicroClave Clear connectors and a NanoClave T-Connector.
Look for lot numbers 4475297 or 4711598 on the packaging to identify affected units.
The internal surface of the NanoClave connector in specific lots may have a manufacturing defect that could inhibit proper sealing with the NanoClave spike.
Check for lot numbers 4475297 or 4711598 on the packaging. The product is a 5.5" (14 cm) Smallbore Trifuse Ext Set with 3 MicroClave Clear connectors and a NanoClave T-Connector.
The recall 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-0259-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0259-2021 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.
