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U.S. Department of Health and Human Services

Class 2 Device Recall GelPOINT Path Transanal Procedural Pack

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  Class 2 Device Recall GelPOINT Path Transanal Procedural Pack see related information
Date Initiated by Firm December 12, 2018
Create Date November 21, 2019
Recall Status1 Terminated 3 on January 22, 2021
Recall Number Z-0510-2020
Recall Event ID 83909
510(K)Number K171701  
Product Classification Anoscope and accessories - Product Code FER
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.
Code Information Model Number: TA211 Lot Numbers: 1342169 and 1340118
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Lauren Contursi
949-713-8000
Manufacturer Reason
for Recall		 Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FER and Original Applicant = Applied Medical Resources Corp.
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