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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH

Hazard

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Details from the source

Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. Distribution: Worldwide distribution. Lot/code info: DYNDH1446A, Lot Number 2020102990; MNS11965A, Lot Number 2021061190; MNS11965A, Lot Number 2021072690; MNS11965A, Lot Number 2021083090; MNS11965A, Lot Number 2022041390; MNS11965A, Lot Number 2022091490; MNS11965A, Lot Number 2023041090; MNS12670A, Lot Number 2023060290; DYNDH1512, Lot Number 2021100490; CIT7095, Lot Number 2021061190; CIT6535, Lot Number 2024031880; CIT7020, Lot Number 2021120990; CIT6720, Lot Number 2022032290; CIT6715, Lot Number 2022062290; CIT7210, Lot Number 2022071990; CIT7020, Lot Number 2022091490; CIT7210, Lot Number 2022120590; CIT6715, Lot Number 2023012490; CIT7020, Lot Number 2023030290; CIT7210, Lot Number 2023030990; CIT7210, Lot Number 2023060290; CIT6925, Lot Number 2021081190; CIT6925, Lot Number 2021090290; CIT6925, Lot Number 2022070590; UVT1030, Lot Number 2021072190; UVT1030, Lot Number 2022032290; CIT6780, Lot Number 2021081650; CIT6780, Lot Number 2023092290; CIT6920, Lot Number 2024020290; CIT4845, Lot Number 2023042090; CIT4845, Lot Number 2023070390; CIT4845, Lot Number 2023081090; MNS8245, Lot Number 2022111890; MNS12465, Lot Number 2022072290; MNS12465, Lot Number 2022111890; MNS12465, Lot Number 2023042890; MNS12465, Lot Number 2023102390; MNS12465, Lot Number 2024022190; MNS12465, Lot Number 2024030790; MNS12465, Lot Number 2022022880; DYNDA2496, Lot Number 2023102590

Source

Official record: FDA (Device enforcement)

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

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