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 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 50 pouches of NanoClave sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The defect may prevent the NanoClave set from forming a proper seal with the spike, which is critical for safe fluid administration. This could lead to improper fluid delivery or leakage during medical procedures.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Look for the product name 'NanoClave' with the lot number 4714442 and UDI code (01)10887709040264(17)250201(30)50(10)4714442. The sets come in 50 pouches per case.
Verify the lot number and UDI code on the packaging to confirm if your set is affected.
The recall states there is 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, totaling 1 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-0253-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0253-2021 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.
