Home / Recalls / Applied Medical Resources Corp / Z-0510-2020

Z-0510-2020 Class II Terminated

Recalled by Applied Medical Resources Corp — Rancho Santa Margarita, CA

Recall Details

Product Type
Devices
Report Date
November 27, 2019
Initiation Date
December 12, 2018
Termination Date
January 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39 units Domestically and 112 units Internationally

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Model Number: TA211 Lot Numbers: 1342169 and 1340118

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