ICU Medical recalls 50 units of NanoClave sets with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the spike, risking improper administration of fluids.
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 50 units of NanoClave sets with specific lot numbers because a manufacturing defect might prevent the device from sealing correctly 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 for patients.
Healthcare professionals using these specific NanoClave sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could face complications if the seal fails.
Check the lot numbers: 4568886, 4605109, 4630689, or 4733556. These units come in 50 pouches per case and are labeled as 9 inches (23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter.
Verify the lot numbers on the device: 4568886, 4605109, 4630689, or 4733556.
The internal surface of the NanoClave may have a manufacturing defect that could inhibit a proper seal with the spike.
50 units per case, with specific lot numbers: 4568886, 4605109, 4630689, and 4733556.
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-0190-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0190-2021 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.
