Device product
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
Z-1211-2017
Product summary
- Event
- Event 75707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases (18 units)
- Official record key
device-enforcement:Z-1211-2017
Official wording
Reason: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information: Lot Number: 243312
Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Derived failure modes
-
Unknown
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.