ICU Medical recalls 25 pouches of 83" smallbore ext sets with a potential seal defect that could cause improper connection to NanoClave spikes. Affected units have specific UDI codes. Consumers should 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 25 pouches of 83-inch smallbore extension sets due to a possible manufacturing defect that might prevent proper sealing with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave stopcock may have a manufacturing defect that prevents it from sealing properly with the spike. This could cause improper fluid administration during medical procedures, potentially leading to patient complications.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the UDI code (01)1088770:9089508(17)250101(30)25(10)4548244 on the packaging. The product is a single-use sterile device sold in 25 pouches per case.
Look for the UDI code (01)10887709089508(17)250101(30)25(10)4548244 on the packaging to confirm if your unit is affected.
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, which could lead to improper fluid administration during medical procedures.
Check for the UDI code (01)10887709089508(17)250101(30)25(10)4548244 on the packaging. The product is sold in 25 pouches per case.
The recall record 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-0221-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0221-2021 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.
