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FDA (Device enforcement)Recalled 2025-09-08class ii

ICU Medical, Inc.: ChemoLock Bag Spike, 01 units REF: CL-10-10

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: 875 units Lot/code info: UDI:10887709071022/Lot: 14397202

UPC codes

10887709071022

Source

Official record: FDA (Device enforcement)

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

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