Flowonix Medical Inc recalls Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YY…

Recall date

December 24, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1125-2020

FDA classification

Class II

Brand / firm

Flowonix Medical Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)