ICU Medical recalls 25 pouches of 15-drop sets with potential seal defects that could cause improper administration. Affected units have specific lot numbers and UDI codes.
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 pouches of 15-drop sets that may have a manufacturing defect causing improper sealing. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave may have a defect that prevents it from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
Healthcare professionals using these sets for patient intravenous fluid administration. Patients receiving treatments through these sets are at risk if the seal fails.
Check for the lot number 4733705 and UDI code (01)10887709088501(17)250201(30)25(10)4733705 on the packaging. The product is a single-use sterile intravenous set.
Look for the lot number 4733705 and UDI code on the packaging to confirm if your set is affected.
The internal surface of the NanoClave may have a manufacturing defect that prevents proper sealing with the spike.
Check for the lot number 4733705 and UDI code (01)10887709088501(17)250201(30)25(10)4733705 on the packaging.
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-0225-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0225-2021 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.
