ICU Medical recalls 5" Smallbore Bifuse Ext Sets with NanoClave T-Connectors due to potential manufacturing defect that may inhibit proper seal with the spike. Affected units have specific UDI codes.
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 medical sets that may have a manufacturing defect causing improper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave component may have a manufacturing defect that prevents it from sealing properly with the spike. This could result in improper fluid administration during medical procedures.
Healthcare professionals using the specific medical sets for intravenous fluid administration are most at risk. Patients receiving treatment with these sets could be affected if the seal fails.
Look for the product name: 5" (13 cm) Appx 0.39 ml Smallbore Bifuse Ext Set with NanoClave T-Connector. Check the UDI code (01)10887709053028(17)250101(30)50(10)4603262 on the packaging.
Verify the product name and UDI code on the packaging to confirm if it matches the recalled items.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the spike.
Check for the UDI code (01)10887709053028(17)250101(30)50(10)4603262 on the packaging of the 5" Smallbore Bifuse Ext Set with NanoClave T-Connector.
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-0191-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0191-2021 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.
