ICU Medical recalls 50-pouch sets of NanoClave medical connectors due to potential manufacturing defects that could prevent proper sealing with spikes. Affected units have specific lot numbers and may be used for blood/fluid administration in hospitals and clinics.
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-pouch sets of NanoClave medical connectors because a manufacturing defect might prevent them from sealing properly with spikes. This could lead to improper blood/fluid administration in medical settings.
The NanoClave connector has a potential manufacturing defect on its internal surface that could prevent it from sealing correctly with the spike. This might cause improper blood or fluid administration during medical procedures.
Healthcare providers using these connectors for blood and fluid administration in hospitals or clinics. Patients receiving treatments with these devices may be at risk if the seal fails.
Check for the lot number 4605676 on the packaging. The product is a 20cm, 1.3ml external set with a 3-port NanoClave manifold and check valve, sold in 50-pouch cases.
Look for the lot number 4605676 on the packaging to confirm if your unit is affected.
The internal surface of the NanoClave may have a manufacturing defect that could prevent proper sealing with the spike.
Check for the lot number 4605676 on the packaging. The product is a 20cm, 1.3ml external set with a 3-port NanoClave manifold and check valve, sold in 50-pouch cases.
The recall record does not specify any 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-0262-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0262-2021 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.
