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U.S. Department of Health and Human Services

Class 2 Device Recall Epix Electrosurgical Probe with Smoke Evacuation

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  Class 2 Device Recall Epix Electrosurgical Probe with Smoke Evacuation 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-0509-2020
Recall Event ID 83909
510(K)Number K171684  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm
REF CW002 QTY: 1 - Product Usage:
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.
Code Information Model Number: CW002 Lot Numbers: 1336418 and 1340803  Model # Lot # UDI Code CW002 1336418 (01)00607915136147(17)210912(30)01(10)1336418 CW002 1340206 (01)00607915136147(17)211029(30)01(10)1340206 TA211 1340118 (01)20607915139050(17)210812(30)01(10)1340118 TA211 1342169 (01)20607915139050(17)210812(30)01(10)1342169
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 28 units Domestically - 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 = GEI and Original Applicant = Applied Medical Resources Corporation
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