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

Cardinal Health 200, LLC: Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

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 26971564466206 (Case), 16971564466209 (Box), 06971564466202 (Each), Lot Numbers: 230701, 230501

UPC codes

26971564466206, 16971564466209, 06971564466202

Source

Official record: FDA (Device enforcement)

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

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