ICU Medical recalls 50-unit packs of Smallbore Ext Sets with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the NanoClave spike, requiring immediate action.
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-unit packs of Smallbore Ext Sets with specific lot numbers because a manufacturing defect might prevent the NanoClave from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave in specific lots may have a defect that prevents it from creating a proper seal with the spike. This could allow fluid to leak or cause improper administration during medical procedures.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot numbers: 4572718, 4603246, 4718507, 4537122, 4549054, or 4734370. The product is a single-use sterile set sold in 50-pouch cases with a unique identifier code.
Identify the lot numbers on the product: 4572718, 4603246, 4718507, 4537122, 4549054, or 4734370.
If your set has one of these lot numbers, stop using it immediately to prevent potential improper fluid administration.
The internal surface of the NanoClave in specific lots may have a manufacturing defect that prevents it from sealing properly with the spike.
Check the lot numbers: 4572718, 4603246, 4718507, 4537122, 4549054, or 4734370.
The recall record does not specify a return process, 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-0186-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0186-2021 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.
