# FDA recall Z-2942-2018

> **Medical Components, Inc dba MedComp** · Class II · device recall initiated 2018-07-12.

## 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, 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.

## Distribution

Nationwide distribution; worldwide distribution.

## Key facts

- **Recall number:** Z-2942-2018
- **Recalling firm:** Medical Components, Inc dba MedComp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-12
- **Report date:** 2018-09-05
- **Termination date:** 2020-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Harleysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2942-2018

## Citation

> AI Analytics. FDA recall Z-2942-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2942-2018. Source: US FDA. Licensed CC0.

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