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Recall Observatory FDA recall evidence

Device product

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

Z-0486-2024

September 05, 2023

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 93343
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0486-2024

Official wording

Reason: 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.

Code information: UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.

Distribution pattern: US: VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.