ICU Medical, Inc.: ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

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: UDI:10887709057019/Lot: 14386054

UPC codes

10887709057019

Source

Official record: FDA (Device enforcement) ↗

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