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 laparoscop
Check against the official notice below — it lists the full affected range.
Applied Medical Resources Corp is recalling Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip (model CW002, 5mm x 42 cm) due to unintentional shifting of the tip insulation on the probes. A total of 28 units were distributed domestically across the United States, and 112 units were distributed internationally to Belgium, Germany, Switzerland, Spain, Finland, France, Great Britain, Israel, India, Italy, Lebanon, Netherlands, and Portugal. The affected devices are identified by lot numbers 1336418 and 1340803 for model CW002, and lot numbers 1340206, 1340118, and 1342169 for model TA211.
The source document does not specify a remedy or what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
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. Quantity: 28 units Domestically - 112 units Internationally Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.