FDAFDA · Food and drugs·Recall number Z-2280-2016
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Published August 3, 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 Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax Medical Company
- Distributor
- US Nationwide Distribution
- Lot
- Model #'s FS-34V, ES-3831, ES-3870K and ES-3840
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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