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FDA (Device enforcement)Recalled 2025-11-26class ii

Medline Industries, LP: Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU

Hazard

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Details from the source

Reason for recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. Distribution: US Nationwide distribution. Quantity: 32 units Lot/code info: Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843; Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327; Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.

UPC codes

10889942695911, 40889942695912, 10198459418143, 40198459418144, 10198459316593, 40198459316594

Source

Official record: FDA (Device enforcement)

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

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