FDAFDA · Food and drugs·Recall number Z-0961-2014
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Published March 5, 2014 · Recall initiated: January 6, 2014
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
The tracheal tube can kink during patient use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
- Lot
- Product Code: 5-14016, Lot numbers: 01B1200214, 01E1200462, 01B1200335, 01C1200468, 01J1300036 and 01J1300339.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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