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ICU Medical, Inc. recalls ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger
Recalled November 5, 2025 · FDA recall Z-0359-2026 · 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
11000 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 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →