ICU Medical recalls 60" (152 cm) Appx 1.:2 ml Ext Set with potential port leak. Affected units have specific UDI and lot numbers. Stop using immediately to prevent leaks.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling a specific IV line set due to a risk of the drug transfer port leaking during use. This could lead to medication exposure or contamination if the port separates. Affected units have a unique identifier and lot number.
The port weld in the drug transfer device may separate or break during use, causing a leak. This leak could expose patients or healthcare workers to medication or contaminants. The risk is highest during IV treatments when the device is in active use.
Healthcare professionals using the ICU Medical 60" (152 cm) Appx 1.2 ml Ext Set with the specified UDI and lot number are most at risk. Patients receiving IV treatments with this set could be exposed to leaks.
Check for the product name 'ICU Medical 60" (152 cm) Appx 1.2 ml Ext Set' with the red cap. Affected units have UDI:10887709123080 and Lot: 14351926.
Discontinue use of the affected IV set to prevent potential leaks.
No, the product is recalled due to a risk of port leaks during use.
UDI: 10887709123080, Lot: 14351926
Check for the product name 'ICU Medical 60" (152 cm) Appx 1.2 ml Ext Set' with the red cap and verify the UDI and lot number.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0339-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0339-2026 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.
