ICU Medical recalls 50 pouches of Smallbore Set 6-Port NanoClave Manifold (lots 4558621, 4573963, 4515215) due to potential seal failure with the spike. Affected units may not seal properly during use.
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 pouches of Smallbore Set 6-Port NanoClave Manifold that could have a manufacturing defect causing improper sealing with the NanoClave spike. This defect may lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave manifold in specific lots may have a manufacturing defect that prevents it from sealing properly with the NanoClave spike. This could result in improper fluid administration during medical procedures.
Healthcare professionals using the recalled sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could experience improper fluid delivery if the seal fails.
Check for the lot numbers 4558621, 4573963, or 4515215 on the packaging. The product is a single-use sterile device sold in pouches of 50 units per case.
Look for lot numbers 4558621, 4573963, or 4515215 on the packaging to identify affected units.
The internal surface of the NanoClave manifold in specific lots may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
50 pouches per case, with each pouch containing 1 unit of the Smallbore Set 6-Port NanoClave Manifold.
The recall record does not specify a remedy for this issue.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0241-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0241-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
