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

MEDLINE INDUSTRIES, LP - Northfield: Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROG

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 Lot/code info: ART245C, Lot Number 2023101990; ART1170, Lot Number 2022121990; ART1170, Lot Number 2023012790; ART1170, Lot Number 2023021590; PT220, Lot Number 2021061490; PT220, Lot Number 2022011090; MNS12670A, Lot Number 2021060190; MNS12670A, Lot Number 2022011090; MNS12670A, Lot Number 2023022190; MNS12670A, Lot Number 2023101890; SUT20455, Lot Number 2021060190; SUT20455, Lot Number 2022011090; SUT20455, Lot Number 2023012390; BT1060, Lot Number 2020062490; BT1015, Lot Number 2021060190; DYNDH1137C, Lot Number 2021091490; DYNDH1137C, Lot Number 2022121990; SPEC4380, Lot Number 2018102950; SPEC4380, Lot Number 2023032390; DYNJTS0214, Lot Number 2022061790; DYNJTS0214, Lot Number 22121990; SPEC0130C, Lot Number 2023022190; S5078BF09, Lot Number 2020051850; S5078BF09, Lot Number 2022092290; CHT560, Lot Number 2018042790; CHT560, Lot Number 2018050790; CHT560, Lot Number 2018060490; CHT560, Lot Number 2018080790; CHT560, Lot Number 2018091190; CHT560, Lot Number 2020032490; CHT560, Lot Number 2020051990; CHT560, Lot Number 2020062490; CHT560, Lot Number 2020070190; CHT560, Lot Number 2020071490; CHT560, Lot Number 2020121590; CHT560, Lot Number 2021042690; CHT560, Lot Number 2021082390; CHT560, Lot Number 2021091490; CHT560, Lot Number 2022022490; CHT560, Lot Number 2022050490; CIT7050C, Lot Number 2023081480; CIT7050C, Lot Number 2023101680; CIT7050C, Lot Number 2024010590; DYNJ05162, Lot Number 2020082050; ECVC7860, Lot Number 2023101990; CHT1570A, Lot Number 2021051290; MNS12150, Lot

Source

Official record: FDA (Device enforcement)

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

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