Z-2067-2016 Class II Terminated
FDA device recall Z-2067-2016 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: 50 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
- 50 units
Product Description
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct 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 FCP-8P and FCP-9P