Atrium Medical Corporation: Medical Device Recall in 2023 - (Recall #: Z-0485-2024)

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: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

Product Classification:

Class II

Date Initiated: September 5, 2023

Date Posted: December 13, 2023

Recall Number: Z-0485-2024

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: 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.

Distribution Pattern:

US: VA

Voluntary or Mandated:

Voluntary: Firm initiated