Atrium Oasis Drain Single W / AC, Part No. 3600-100
FDA device recall Z-0621-2024 · posted 2023-12-28 · Open, Classified
Recall details
- Recalling firm
- Atrium Medical Corporation
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CAC
- Quantity affected
- 835 cases total (6 units/case)
- Distribution
- Domestic distribution nationwide. No foreign distribution.
- Date initiated
- 2023-11-01
- Date posted
- 2023-12-28
- Location
- Merrimack, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPRESS AND OASIS CHEST DRAIN (K043140) | Atrium Medical Corp. | 2004-12-08 |