Epix Electrosurgical Probes with Smoke Evacuation, Angled… recallZ-0509-2020 · Applied Medical Resources Corp · initiated Dec 12, 2018

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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 [email protected] 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 [email protected]. For regulatory questions, to contact (949) 713-8767 or by email at [email protected].

Recall details

Recall number

Z-0509-2020

Status

Terminated

Initiated by the company

Dec 12, 2018

Recalling firm

Applied Medical Resources Corp

Quantity

28 units Domestically - 112 units Internationally

Product code

GEI

FDA submissions

K171684

Distribution

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

Product description

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Epix Electrosurgical Probe with Smoke Evacuation - L-Hook CW002

  Applied Medical Resources Corporation · Electrosurgical, Cutting & Coagulation & Accessories
  1 recall6 reports
• GelPoint Path Transanal Procedural Pack TA211

  Applied Medical Resources Corporation · Electrosurgical, Cutting & Coagulation & Accessories
  1 recall0 reports