medical Class II Updated 2023-12-13

Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number

Recalled Product

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

Hazard / Issue

Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

Issued by

FDA

Affected States: VA
Lot/Code Info: UDI-DI: 20650862110016. Lots: 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055, 471797, 472571, 474505, 477919, 480204, 480205, 480658, 482038, 483030, 483794, 484519, 484521, 484530, 486156, 486531, 487059, 488305, 489762.
View official government recall

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