ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, C...
FDA Recall #Z-0338-2026 — Class II — September 8, 2025
Product Description
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Reason for Recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Recalling Firm
ICU Medical, Inc. — San Clemente, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
950 units
Distribution
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.
Code Information
UDI:10887709098388/Lot: 14400230
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated