Pentax Medical Company recalls Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. Thi

Recalled July 6, 2016 · FDA recall Z-2066-2016 · Pentax Medical

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. · FDA Class II

Units

126 units

Sold at

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Description

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.

Product

Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Manufacturer(s)

Pentax Medical Company

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →