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FDA (Device enforcement)Recalled 2023-12-28class i

Cardinal Health 200, LLC: Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T

Hazard

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Details from the source

Reason for recall: Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts. Distribution: Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada. Lot/code info: UDI/DI 50192253025833 (Case), 20192253025832 (Box), 10192253025835 (Each), Lot Numbers: 221101, 230601

UPC codes

50192253025833, 20192253025832, 10192253025835

Source

Official record: FDA (Device enforcement)

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

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