# FDA recall Z-2938-2018

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

## Product

Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M

## 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-2938-2018
- **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-2938-2018

## Citation

> AI Analytics. FDA recall Z-2938-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2938-2018. Source: US FDA. Licensed CC0.

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