DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Nationwide distribution; worldwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2942-2018