An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Reason for recall: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment Distribution: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA Quantity: 44 units (5/box); 133 units (5/box) OUS Lot/code info: UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559
00821925044579
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.