ICU Medical recalls 50 pouches of NanoClave sets with potential manufacturing defect causing improper sealing. This could lead to contamination during drug preparation. 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 NanoClave spike. This could allow environmental contaminants to enter the system during drug preparation, potentially exposing healthcare workers to hazardous drugs.
The manufacturing defect may prevent the NanoClave from creating a proper seal with the spike. This could allow environmental contaminants, including bacteria and airborne particles, to enter the system during drug preparation. The risk is to healthcare workers handling the sets.
Healthcare professionals using the NanoClave sets for drug preparation are most at risk. The recall affects specific lots of the 50-pouch sets sold to hospitals and clinics.
Check for the UDI code (01)10887709098878(17)241201(30)50(10)4493149 on the packaging. The affected sets have a specific lot number: 4493149 and are sold in 50-pouch cases.
Verify the UDI code and lot number on the packaging to confirm if your set is affected.
The recall states there is a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the NanoClave spike.
Check for the UDI code (01)10887709098878(17)241201(30)50(10)4493149 and lot number 4493149 on the packaging.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0248-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0248-2021 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.
