PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 5, 2018 Initiated: July 12, 2018 #Z-2942-2018

Product Description

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)

Reason for Recall

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.

Details

Units Affected
N/A
Distribution
Nationwide distribution; worldwide distribution.
Location
Harleysville, PA

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by Medical Components, Inc dba MedComp. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2942-2018.

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