Home / Recalls / Medical Devices
ICU Medical, Inc. recalls ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Recalled November 5, 2025 · FDA recall Z-0358-2026 · ICU Medical
Hazard
Port weld of drug transfer device may separate or break during use and potentially result in a leak. · FDA Class II
Units
2450 units
Sold at
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.
Description
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Product
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →