It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Reason for recall: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada. Quantity: 140 units Lot/code info: Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586
04046963620042
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.