FDA recall Z-0510-2020

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-12-12

Report date

2019-11-27

Termination date

2021-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2020