Z-2075-2016 Class II Terminated
FDA device recall Z-2075-2016 was initiated by Pentax Medical Company on April 6, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 21, 2017). Affected quantity: 1,596 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2016
- Initiation Date
- April 6, 2016
- Termination Date
- December 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,596 units
Product Description
Signmoidoscope 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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Code Information
Model #'s FS-34V, ES-3831, ES-3870K and ES-3840