ICU Medical, Inc.: ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

Hazard

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Details from the source

Reason for recall: Port weld of drug transfer device may separate or break during use and potentially result in a leak. 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. Quantity: 11000 units Lot/code info: Lot:14397353, 14418912; Distributed in Canada

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.