Recall Z-0510-2020

Reason for recall

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

FDA-determined cause: Device Design

Action taken

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.