Recall Z-0509-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Applied Medical Resources Corp
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
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171684 | Epix Electrosurgical Probe with Smoke Evacuation Applied Medical Resources Corporation, Aug 7, 2017 |