ICU Medical recalls specific NanoClave sets that may not seal properly with the spike due to a manufacturing defect. Affected units have a unique UDI code. 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 certain NanoClave sets that may not seal properly with the spike due to a manufacturing defect. This could lead to improper fluid administration during medical procedures. Affected units have a specific UDI code and were sold in limited quantities.
The manufacturing defect on the internal surface of the NanoClave may prevent it from creating a proper seal with the spike. This could result in improper fluid administration during medical procedures if the set is used without a proper seal.
Healthcare professionals using the NanoClave sets for medical procedures are most at risk. The recall affects specific units sold in limited quantities with a unique UDI code.
Check for the UDI code (01)10887709069524(17)250201(30)50(10)4711196 on the packaging. The affected units were sold in 50-pouch cases with a specific lot number (4711196).
Look for the UDI code (01)10887709069524(17)250201(30)50(10)4711196 on the packaging to identify affected units.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the spike.
Check for the UDI code (01)10887709069524(17)250201(30)50(10)4711196 on the packaging. Affected units were sold in 50-pouch cases with lot number 4711196.
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-0238-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0238-2021 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.
