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Applied Medical Resources Corp recalls GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm
Recalled November 27, 2019 · FDA recall Z-0510-2020 · Applied Medical Resources
Hazard
Unintentional shifting of the tip insulation of the firm's electrosurgical probes. · FDA Class II
Units
39 units Domestically and 112 units Internationally
Sold at
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Description
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Product
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.
Manufacturer(s)
Applied Medical Resources Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →