Z-0621-2024Class II

Atrium Oasis Drain Single W / AC, Part No. 3600-100

Name: Z-0621-2024 Atrium Oasis Drain Single W / AC, Part No. 3600-100
Creator: Atrium Medical Corporation
Published: 2023-11-01
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2023-11-01 / Open, Classified / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Atrium Oasis Drain Single W / AC, Part No. 3600-100 on 2023-11-01. FDA classified it as Class II and gives the reason as "A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0621-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-01
Posted: 2023-12-28
Recalling firm: Atrium Medical Corporation
Product: Atrium Oasis Drain Single W / AC, Part No. 3600-100
Product code: CAC Apparatus, Autotransfusion
Reason for recall: A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On November 1, 2023, the firm issued URGENT MEDICAL DEVICE - Removal letters to affected customers. Customers were instructed to remove any product from the affected lots from areas of use. Customers with affected product are entitled to a replacement at no cost to their facility. Customers will receive replacements upon their acknowledgement that they have affected product for return. Distributors should forward recall documentation to affected customers. Customers with questions may contact their Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, 9AM-6PM Eastern Time Zone.
Quantity in commerce: 835 cases total (6 units/case)
Distribution: Domestic distribution nationwide. No foreign distribution.
Product codes and lots: UDI-DI 00650862110012 Lots 492065 and 492075

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0621-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0621-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-03	2023-12-28

Product code CAC

K043140Class IIExpress and Oasis Chest DrainAtrium Medical Corp. / cleared 2004-12-08

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)