Z-2277-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- April 6, 2016
- Termination Date
- July 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 433 units
Product Description
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model #'s FD-34V and ED-3490TK