ICU Medical recalls 50 units of smallbore IV sets with potential seal defects that could cause improper connections during medical use. Affected units have specific UDI codes and lot numbers.
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 smallbore IV sets that may have a manufacturing defect causing improper sealing with the needle. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave may have a defect that prevents it from sealing properly with the needle. This could cause improper fluid administration during medical procedures.
Healthcare professionals using these IV sets for patient care. Patients receiving IV treatments with the affected sets are at risk of improper fluid administration.
Look for the product name: 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave. Check the UDI code (01)10887709099859(17)241201(30)50(10)4536666 and lot number 4536666.
Verify the product name and UDI code to confirm if your set is affected.
The internal surface of the NanoClave may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check for the product name: 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, and the UDI code (01)10887709099859(17)241201(30)50(10)4536666 with lot number 4536666.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0274-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0274-2021 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.
