ICU Medical recalls 50-pouch sets with specific lot numbers for potential seal failure during use. Affected units may not seal properly with the spike, risking improper fluid administration.
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 small-bore Quadfuse sets that could have a manufacturing defect causing the seal to fail with the spike. This might lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave in specific lots may not seal properly with the spike. This could allow fluid to leak or not be delivered correctly during medical procedures.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatment with the recalled sets could be affected if the seal fails.
Check for lot numbers 4735112 or 4493240 on the packaging. The product is a 15 cm (6 inch) Smallbore Quadfuse Ext Set with 4 NanoClave spikes per pouch, sold in 50-pouch cases.
Look for lot numbers 4735112 or 4493240 on the packaging to identify affected units.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the spike.
Check the lot numbers on the packaging. If your product has lot numbers 4735112 or 4493240, stop using it and contact ICU Medical for instructions.
The recall states a potential seal failure, which could lead to improper fluid administration, but the official notice does not specify a risk of serious injury.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0268-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0268-2021 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.
