FDAFDA · Food and drugs·Recall number Z-0351-2026
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Published November 5, 2025 · Recall initiated: September 8, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
- Lot
- UDI:10887709071398/Lot:14397348, 14377757
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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