# FDA recall Z-1975-2019

> **Teleflex Medical** · Class III · device recall initiated 2019-01-14.

## Product

RUSCH Urinary Drainage bag, 2000mlm REF 390060     urine collection device

## Reason for recall

The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.

## Key facts

- **Recall number:** Z-1975-2019
- **Recalling firm:** Teleflex Medical
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-14
- **Report date:** 2019-07-24
- **Termination date:** 2022-12-13

- **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-1975-2019

## Citation

> AI Analytics. FDA recall Z-1975-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1975-2019. Source: US FDA. Licensed CC0.

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