ICU Medical recalls specific NanoClave sets due to a potential manufacturing defect that may prevent proper sealing with the spike. Affected units include certain lot numbers and packaging. Consumers should check their UDI codes and contact the company for details.
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 specific NanoClave sets that may have a manufacturing defect causing improper sealing with the spike. This could lead to improper fluid administration during medical procedures. Affected units have unique UDI codes listed in the recall notice.
The defect may prevent the NanoClave from sealing properly with the spike, which could lead to improper fluid administration during medical procedures. This might cause complications if the seal fails during use, but the risk is not described as causing serious injury in normal use.
Healthcare professionals using these specific NanoClave sets for medical fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the UDI codes: 4718517, 4514500, or 4727354 on the packaging. The product is a single-use set with 1 unit per pouch and 50 pouches per case.
Look for the UDI codes 4718517, 4514500, or 4727354 on the packaging to identify affected units.
The recall states there is a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
Check the UDI codes on the packaging: 4718517, 4514500, or 4727354. The product is a single-use set with 1 unit per pouch and 50 pouches per case.
The recall does not specify a remedy, so contact ICU Medical directly for further 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-0264-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0264-2021 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.
