ICU Medical recalls 50 pouches of NanoClave sets with a potential seal defect that could cause improper connections during medical use. Affected units have specific UDI codes and are single-use medical devices.
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 NanoClave sets due to a possible manufacturing defect that might prevent proper sealing with the spike. This could lead to improper connections during medical procedures, which is serious for patients.
The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing correctly with the spike. This could cause improper connections during medical procedures, potentially leading to patient complications.
Healthcare professionals using these sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could face complications from improper connections.
Check for the UDI code (01)10840619066052(17)250201(30)50(10)4717491 on the packaging. These sets are single-use medical devices sold in 50-pouch cases.
Look for the UDI code (01)10840619066052(17)250201(30)50(10)4717491 on the packaging to identify affected units.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave that may inhibit proper sealing with the spike.
50 pouches per case, with one unit per pouch.
Check the UDI code on the packaging to see if it matches the affected code (01)10840619066052(17)250201(30)50(10)4717491.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0266-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0266-2021 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.
