MedComp Recalls Duo Flow Double Lumen Catheters Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling Duo Flow double lumen catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, and air emboli.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of serious harm (bleeding, air emboli) but no reported serious injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medical Components, Inc dba MedComp is recalling specific models of Duo Flow double lumen catheters and Raulerson Duo Flow IJ double lumen catheter sets. The recall involves multiple product codes and catalog numbers, including XTP114CT, XTP114MT, XTP114IJC, and XTP116IJS, among others. The products were distributed nationwide and worldwide.
The recall was initiated because the suture wings on the catheters have the potential to crack or break. This malfunction creates a potential for patient injury, including catheter dislocation, bleeding, and air emboli. The firm has received six complaints regarding malfunction, involving 29 broken suture wings, to date. No serious injuries or deaths have been reported in connection with these complaints.
Healthcare facilities and consumers should stop using the affected catheters immediately. Users should check their inventory for the specific product codes and catalog numbers listed in the recall notice. For more information, contact the recalling firm or refer to the FDA recall number Z-2942-2018.
The recalled product
- Product
- 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,
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheters
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medical Components, Inc dba MedComp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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