FDAFDA · Food and drugs·Recall number Z-1205-2017
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.
Published February 22, 2017 · Recall initiated: December 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atrium Medical Corporation
- Distributor
- Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
- Lot
- Lot Number: 242896, 243292
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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