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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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