Z-0485-2024 Class II Ongoing
FDA device recall Z-0485-2024 was initiated by Atrium Medical Corporation on September 5, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- September 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Reason for Recall
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.
Distribution Pattern
US: VA
Code Information
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.