# FDA recall Z-1124-2020

> **Flowonix Medical Inc** · Class II · device recall initiated 2019-12-24.

## Product

Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)

## Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

## Distribution

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

## Key facts

- **Recall number:** Z-1124-2020
- **Recalling firm:** Flowonix Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-12-24
- **Report date:** 2020-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2020

## Citation

> AI Analytics. FDA recall Z-1124-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1124-2020. Source: US FDA. Licensed CC0.

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