# FDA recall Z-0797-2020

> **Teleflex Medical** · Class III · device recall initiated 2019-02-27.

## Product

Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

## Reason for recall

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

## Distribution

ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

## Key facts

- **Recall number:** Z-0797-2020
- **Recalling firm:** Teleflex Medical
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-27
- **Report date:** 2020-01-22
- **Termination date:** 2023-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2020

## Citation

> AI Analytics. FDA recall Z-0797-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0797-2020. Source: US FDA. Licensed CC0.

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