Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 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-1205-2017
Product Description
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 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
- 245 cases (1470 units)
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
- Location
- Hudson, NH
Frequently Asked Questions
What product was recalled? ▼
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 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: 245 cases (1470 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-1205-2017.
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