Applied Medical Resources Corp recalls GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm…

Recall date

December 12, 2018

Source

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

Recall number

Z-0510-2020

FDA classification

Class II

Brand / firm

Applied Medical Resources Corp

Sold / distributed

Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.

Why it was recalled

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

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

What was recalled

GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.