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: 26 units Lot/code info: Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
04046963425272
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.