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

MEDLINE INDUSTRIES, LP - Northfield: Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack

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: DYNDH1349, Lot Number 2019061090; SPEC0400, Lot Number 2022010790; SPEC0400, Lot Number 2022061490; PT220, Lot Number 2020090390; DYNDH1570, Lot Number 2023091390; SPEC4380, Lot Number 2023110890; DYNDH1050A, Lot Number 2019100490; SPEC0130C, Lot Number 2020072090; DT5490B, Lot Number 2022091590; S5078BF09, Lot Number 2022122390; CHT705, Lot Number 2021072990; CIT6260, Lot Number 2022031190; MNS4815, Lot Number 2022042890; MNS6496, Lot Number 2018112690; MNS6496, Lot Number 2019061390; MNS6496, Lot Number 2020040190; MNS6496, Lot Number 2020062290; MNS6496, Lot Number 2020090290; MNS6496, Lot Number 2021072990; MNS6496, Lot Number 2022010790; MNS6496, Lot Number 2022080890; MNS6496, Lot Number 2022122390; MNS6496, Lot Number 2023040690; MNS2925A, Lot Number 2019080690; MNS2925A, Lot Number 2019101190; MNS2925B, Lot Number 2020032090; MNS2925B, Lot Number 2020071690; DYNDL1187A, Lot Number 2019080590; DYNDL1187A, Lot Number 2019100490; SUT19360, Lot Number 2023021090; SPEC0248B, Lot Number 2019041790; DYNDA2524, Lot Number 2019100490; DYNDH1227A, Lot Number 2019061090; DYNDH1227B, Lot Number 2019100490; MNS12150, Lot Number 2021072990; MNS12150, Lot Number 2022031190; DYNDL1757, Lot Number 2019061090; DYNDH1531, Lot Number 2023021090; MNS3355, Lot Number 2019080590; MNS3355, Lot Number 2019100490; MNS3355, Lot Number 2020050890; MNS3355, Lot Number 2020091090; MNS3355, Lot Number 2020113090; MNS3355, Lot Number 2021030890; MNS3355, Lot Number 2021040990; MNS3355, Lot Number 20

Source

Official record: FDA (Device enforcement)

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

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