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GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4...

FDA Recall #Z-0510-2020 — Class II — December 12, 2018

Recall #Z-0510-2020 Date: December 12, 2018 Classification: Class II Status: Terminated

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.

Recalling Firm

Applied Medical Resources Corp — Rancho Santa Margarita, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

39 units Domestically and 112 units Internationally

Distribution

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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