Flowonix Medical Inc: Medical Device Recall in 2020 - (Recall #: Z-1124-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 24, 2019

Date Posted: February 19, 2020

Recall Number: Z-1124-2020

Event ID: 84653

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.

Status: Ongoing

Product Quantity: 1083 (OUS)

Code Information:

All units with pump firmware version 0.26 manufactured from 2012 until the present time.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated