ICU Medical recalls specific NanoClave sets due to a potential manufacturing defect that may inhibit proper sealing with the spike. Affected units have lot number 4537141. Consumers should check their product details and contact the company for instructions.
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 certain NanoClave sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications.
Healthcare professionals using these sets for medical procedures are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot number 4537141 on the product packaging. The affected sets are 10" (25 cm) Appx 2.8 ml Trifuse Ext Sets with 3 MicroClaves, a Tri-Connector, and 4 clamps (red, white, blue).
Look for the lot number 4537141 on the packaging to confirm if your set is affected.
The internal surface of the NanoClave may have a manufacturing defect that could inhibit a proper seal with the spike.
Check for the lot number 4537141 on the packaging. The affected sets are 10" (25 cm) Appx 2.8 ml Trifuse Ext Sets with 3 MicroClaves, a Tri-Connector, and 4 clamps (red, white, blue).
The recall 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-0188-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0188-2021 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.
