Atrium Medical Corporation: Medical Device Recall in 2023 - (Recall #: Z-0486-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 5, 2023

Date Posted: December 13, 2023

Recall Number: Z-0486-2024

Event ID: 93343

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.

Status: Ongoing

Product Quantity:

Code Information:

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

Distribution Pattern:

US: VA

Voluntary or Mandated:

Voluntary: Firm initiated