ICU Medical recalls 25-pouch sets of NanoClave IV administration sets due to potential manufacturing defect causing improper sealing with the spike. Affected units have specific 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 25-pouch sets of NanoClave IV administration sets because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The defect may cause the NanoClave to not seal properly with the spike, potentially allowing fluid to leak or not deliver medication correctly during medical procedures. This could lead to improper treatment or complications for patients.
Healthcare professionals using these IV sets for patient care are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for lot numbers 4711277 or 4719610 on the packaging. The product is a single-use IV set with specific measurements and packaging details.
Look for lot numbers 4711277 or 4719610 on the packaging to identify affected units.
The recall states a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the NanoClave spike.
Check for lot numbers 4711277 or 4719610 on the packaging. The product is a single-use IV set with specific measurements and packaging details.
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-0256-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0256-2021 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.
