US Endoscopy Group Inc recalls Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissec…

Recall date

July 14, 2015

Source

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

Recall number

Z-0001-2016

FDA classification

Class II

Brand / firm

US Endoscopy Group Inc

Sold / distributed

US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.

Why it was recalled

The company has determined the sterility cannot be assured for the affected lot.

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

What was recalled

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.