ICU Medical recalls specific lots of Smallbore Trifuse Ext Sets with NanoClave due to potential seal failure risk. Affected units may not seal properly with the spike, causing 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 specific lots of Smallbore Trifuse Ext Sets with NanoClave due to a potential manufacturing defect that could prevent proper sealing with the spike. This risk may lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave in specific lots may have a manufacturing defect that prevents it from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures.
Healthcare professionals using the recalled sets for intravenous fluid administration are most at risk. Patients receiving treatments with these sets could experience improper fluid delivery.
Check for the lot numbers: 4590847, 4572752, 4718535, or 4733570. The product includes a T-connector with 3 MicroClave rings (yellow, green, purple) and 4 clamps.
Look for the lot numbers 4590847, 4572752, 4718535, or 4733570 on the device's UDI.
The internal surface of the NanoClave in specific lots may have a manufacturing defect that prevents proper sealing with the spike.
Check for the lot numbers 4590847, 4572752, 4718535, or 4733570 on the device's UDI.
The recall record does not specify a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0196-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0196-2021 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.
