ICU Medical recalls 9" Smallbore Bifuse Ext Sets with specific lot numbers due to potential seal failure risk with NanoClave spikes. Affected units may not seal properly, risking fluid leakage during medical procedures.
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 smallbore intravenous sets because a manufacturing defect might prevent the NanoClave spike from sealing properly. This could lead to fluid leakage during medical procedures, which is a safety concern for patients receiving IV treatments.
The internal surface of the NanoClave in specific lots may not seal correctly with the spike. This could cause fluid leakage during intravenous administration, potentially leading to complications for patients.
Patients receiving intravenous treatments using the recalled sets are most at risk. Healthcare providers who use these sets for medical procedures may also be affected.
Check the lot numbers: 4536611 or 4557492. The product is a 9" (23 cm) Smallbore Bifuse Ext Set with 2 MicroClave Clear, NanoClave, 3 Clamps, and a 0.2 Micron Filter.
Look for lot numbers 4536611 or 4557492 on the product packaging.
The internal surface of the NanoClave in specific lots may inhibit a proper seal with the NanoClave spike.
Check the lot numbers: 4536611 or 4557492. The product is a 9" (23 cm) Smallbore Bifuse Ext Set with 2 MicroClave Clear, NanoClave, 3 Clamps, and a 0.2 Micron Filter.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0189-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0189-2021 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.
