ICU Medical recalls 113" (287 cm) 10-drop admin sets with possible seal failure. Affected units have specific lot numbers; stop using if you have the product.
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 113-inch (287 cm) 10-drop administration sets that may have a manufacturing defect causing seal issues with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave stopcock in specific lots may not seal properly with the NanoClave spike. This could allow fluid leakage or improper administration during medical procedures.
Healthcare professionals using the recalled admin sets for patient fluid administration are most at risk. Patients receiving treatments with these sets could experience improper fluid delivery.
Look for the product with the lot number 4734446. The set is a 113-inch (287 cm) 10-drop administration set with a clear MicroClave and NanoClave stopcock.
Identify the lot number on the product label; affected units have lot number 4734446.
The internal surface of the NanoClave stopcock in specific lots may not seal properly with the NanoClave spike.
Check the product label for lot number 4734446; the set is a 113-inch (287 cm) 10-drop administration set with a clear MicroClave and NanoClave stopcock.
The recall record 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-0219-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0219-2021 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.
