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 EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167
04046963417710
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.