FDAFDA · Food and drugs·Recall number Z-2073-2016
Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Published July 6, 2016 · Recall initiated: April 6, 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
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax Medical Company
- Distributor
- Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
- Lot
- Model #VNL-1570STK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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