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: 231.4 units (5/box); 510 units (5/box) OUS Lot/code info: UDI-DI: 00821925044555 Lot Numbers: CA191233 CA191234 CA191235 CA233514 CA233515 CA233516 CA233517 CA233518 CA236206 CA236208 CA236213 CA236215 CA236216 CA236217 CA236220 CA236227 CA236228 CA236230 CA236238 CA236240 CA236243 CA236261 CA236272 CA236273 CA236276 CA236278 CA236290
00821925044555
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.