Applied Medical Resources Corp: 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.

Recall number

Z-0510-2020

Recalling firm

Applied Medical Resources Corp

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.

Status

Terminated

Initiated

2018-12-12

Posted

not on file

Terminated

2021-01-22

Reason

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

Root cause

Device Design

Action

On12/12/2018, the firm sent an "URGENT; MEDICAL DEVICE RECALL" notification to customers via UPS informing them that this voluntary recall is being conducted due to the possibility that the insulation near the device tip may unintentionally shift. Customers are asked to: Check their inventory for recalled product. Complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if their facility is returning or has already used units or kits from the lots listed. o If no product is being returned, to please indicate that on the Recall Notification Confirmation Form. Provide a no-charge P.O. number if replacement units or kits are requested. If customer is a distributor, they are instructed to notify any facilities to which they distributed units or kits from the affected lots, and to have them complete the appropriate sections of the Recall Notification Confirmation Form. Return the completed Recall Notification Confirmation Form to Applied Medical by emailing it to recall60787748@appliedmedical.com or faxing it to 949-713-8871. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical following the instructions provided. For product return questions, please contact the Manager of Customer Relations, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions, to contact (949) 713-8767 or by email at lcontursi@appliedmedical.com.

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.

Lot, serial or model codes

Model Number: TA211 Lot Numbers: 1342169 and 1340118

510(k) numbers

["K171701"]

PMA numbers

not on file

Product code

FER

Firm FEI

2027111

Firm city

Rancho Santa Margarita

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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