ICU Medical recalls 50 pouches of NanoClave sets due to potential manufacturing defect that may prevent proper 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 50 pouches of NanoCl:ave sets because a manufacturing defect might prevent the device from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
The defect may cause the NanoClave set to not seal correctly with the spike, potentially allowing fluid to leak or not deliver medication properly during medical procedures.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot number 4718658 on the packaging. The product is a single-use sterile set sold in 50 pouches per case.
Look for lot number 4718658 on the packaging to confirm if your set is affected.
The recall states a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
50 pouches per case, with one unit per pouch.
The recall record does not specify a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0223-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0223-2021 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.
