Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 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
Reported: February 22, 2017 Initiated: December 23, 2016 #Z-1207-2017
Product Description
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 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
Reason for Recall
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 2933 cases (17598 units)
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
- Location
- Hudson, NH
Frequently Asked Questions
What product was recalled? ▼
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 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. Recalled by Atrium Medical Corporation. Units affected: 2933 cases (17598 units).
Why was this product recalled? ▼
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1207-2017.
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