—#204714

Product

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

FDA product code: CAC — Apparatus, Autotransfusion
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K043140
Affected lot / code info: UDI-DI 00650862110012 Lots 492065 and 492075

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Atrium Medical Corporation
Address: 40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern: Domestic distribution nationwide. No foreign distribution.

Timeline

Recall initiated: 2023-11-01
Posted by FDA: 2023-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.