Z-0486-2024 Class II 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: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
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: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.