Z-0509-2020 Class II Terminated
FDA device recall Z-0509-2020 was initiated by Applied Medical Resources Corp on December 12, 2018 and is designated Class II. Reason for recall: Unintentional shifting of the tip insulation of the firm's electrosurgical probes. The recall status is terminated (terminated January 22, 2021). Affected quantity: 28 units Domestically - 112 units Internationally.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- December 12, 2018
- Termination Date
- January 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units Domestically - 112 units Internationally
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.
Reason for Recall
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.
Code Information
Model Number: CW002 Lot Numbers: 1336418 and 1340803 Model # Lot # UDI Code CW002 1336418 (01)00607915136147(17)210912(30)01(10)1336418 CW002 1340206 (01)00607915136147(17)211029(30)01(10)1340206 TA211 1340118 (01)20607915139050(17)210812(30)01(10)1340118 TA211 1342169 (01)20607915139050(17)210812(30)01(10)1342169