Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump...
FDA Recall #Z-1125-2020 — Class II — December 24, 2019
Product Description
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= 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.
Recalling Firm
Flowonix Medical Inc — Mansfield, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1083 (OUS)
Distribution
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
Code Information
All units with pump firmware version 0.26 manufactured from 2012 until the present time.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated