Pentax Medical Company recalls Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or…

Recall date

April 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2072-2016

FDA classification

Class II

Brand / firm

Pentax Medical Company

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.