FDAFDA · Food and drugs·Recall number Z-0799-2015
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Published December 24, 2014 · Recall initiated: November 12, 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
Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
- Lot
- Product Code: 5-10116, Lot number: 01A1400211
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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