Recall Z-0510-2020 ยท FER Anoscope And Accessories
Applied Medical Resources Corp
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.
| Date | Dec 12, 2018 |
| Status | Terminated |
| Reason | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. |
| Root cause | 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 Confirmat |
| Quantity | 39 units Domestically and 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171701 | GelPOINT Path Transanal Access Platform Applied Medical Resources Corp., Jul 20, 2017 |