Z-0486-2024Class II

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

Name: Z-0486-2024 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD...
Creator: Atrium Medical Corporation
Published: 2023-09-05
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2023-09-05 / Open, Classified / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY on 2023-09-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0486-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-05
Posted: 2023-12-02
Recalling firm: Atrium Medical Corporation
Product: Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Product code: CAC Apparatus, Autotransfusion
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The recall notification was issued via Fed-Ex and email on October 5, 2023. It requests (1) immediate quarantine and return of all affected product inventory on hand. (2) for any product further distributed, notify customers that have received affected product to remove the affected devices from use and return them. Questions may be addressed to your Getinge representative or call Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Distribution: US: VA
Product codes and lots: UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0486-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0485-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0486-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code CAC

K043582Class IIOcean Chest DrainAtrium Medical Corp. / cleared 2005-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)