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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) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS133

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: 1725 units Lot/code info: Medline kit SKU DYKS1339B, UDI/DI 10195327386726(EA) 40195327386727 (CS) , Lot Number 25HMC849; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25IMG807; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25JMF937; Medline kit SKU DYKS1359B, UDI/DI 10195327566449(EA) 40195327566440 (CS) , Lot Number 25JMD518; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25HMD322; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25JMG543.

UPC codes

10195327386726, 40195327386727, 10198459523434, 40198459523435, 10195327566449, 40195327566440, 10198459310911, 40198459310912

Source

Official record: FDA (Device enforcement)

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

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