Atrium Oasis Drain Single W / AC, Part No. 3600-100
This recall is currently active, issued December 28, 2023. It was issued by Atrium Medical Corporation.
- Company
- Atrium Medical Corporation
- Recall Initiated
- November 1, 2023
- Posted
- December 28, 2023
- Recall Number
- Z-0621-2024
- Quantity
- 835 cases total (6 units/case)
- Firm Location
- Merrimack, NH
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic distribution nationwide. No foreign distribution.
Lot / Code Info
UDI-DI 00650862110012 Lots 492065 and 492075
Root Cause
Nonconforming Material/Component
Action Taken
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.