Recall Z-0621-2024 ยท CAC Apparatus, Autotransfusion
Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
| Date | Dec 28, 2023 (initiated Nov 1, 2023) |
| Status | Open, Classified |
| 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 ( |
| Quantity | 835 cases total (6 units/case) |
| Distribution | Domestic distribution nationwide. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043140 | EXPRESS AND OASIS CHEST DRAIN Atrium Medical Corp., Dec 8, 2004 |