FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium Oasis Drain Single W / AC, Part No. 3600-100
- Recall number
- Z-0621-2024
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium Oasis Drain Single W / AC, Part No. 3600-100
- Status
- Open, Classified
- Initiated
- 2023-11-01
- Posted
- 2023-12-28
- Terminated
- not on file
- Reason
- 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
- 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
- 835 cases total (6 units/case)
- Distribution
- Domestic distribution nationwide. No foreign distribution.
- Lot, serial or model codes
- UDI-DI 00650862110012 Lots 492065 and 492075
- 510(k) numbers
- ["K043140"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 3011175548
- Firm city
- Merrimack
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28