ICU Medical recalls 5. 5" Smallbore Trifuse Ext Sets with potential seal failure risk. Affected units have specific lot numbers. Consumers should 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 a specific type of smallbore intravenous set due to a potential manufacturing defect that could prevent proper sealing with the NanoClave spike. This defect may 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 NanoClave spike. This could lead to improper fluid administration during medical procedures, potentially causing complications for patients.
Healthcare professionals using the recalled intravenous sets for patient care. Patients receiving treatments with these sets are at risk if the seal fails during administration.
Check for the lot number 4711084 on the packaging. The product is a 5.5" (14 cm) Smallbore Trifuse Ext Set with 3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, and Rotating Luer. It comes in 50 multivac pouches per case.
Identify the lot number on the packaging; affected units have lot number 4711084.
The internal surface of the NanoClave component may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check for the lot number 4711084 on the packaging. The product is a 5.5" (14 cm) Smallbore Trifuse Ext Set with 3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, and Rotating Luer.
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-0211-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0211-2021 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.
