Recall Z-1211-2017 ยท CAC Apparatus, Autotransfusion
Atrium Medical Corporation
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
| Date | Dec 23, 2016 |
| Status | Terminated |
| Reason | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. |
| Root cause | Process control |
| Action | Maquet issued a Field action correction notification sent to customers on 12/23/16 via Fed'x for delivery on Tuesday Dec.27, 2016.who have received affected product and describes the failure mode. Accounts to complete the enclosed Field Notification Reply Form to acknowledge receipt of the notification. Return the Field Notification Reply Form to the following e-mail address: drainsmvv.us@getinge.com or you may fax the form to 1-603-386-6590. Questions, contact your local Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday |
| Quantity | 3 cases (18 units) |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico |
| 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 |