Recall Z-0740-2014 ยท CAC Apparatus, Autotransfusion
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
| Date | Jan 14, 2014 (initiated Nov 19, 2013) |
| Status | Terminated |
| Reason | Chest Drain tubing of of the ATS Blood recovery may leak or disconnect |
| Root cause | Device Design |
| Action | Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line. International Distributors. International |
| Quantity | 42,699 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan. |
| FDA record | Open on fda.gov |