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.
- Recall Initiated
- December 12, 2018
- Terminated
- January 22, 2021
- Recall Number
- Z-0510-2020
- Quantity
- 39 units Domestically and 112 units Internationally
- Firm Location
- Margarita, CA
Reason for Recall
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Distribution
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Lot / Code Info
Model Number: TA211 Lot Numbers: 1342169 and 1340118
Root 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.