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Flowonix Medical Inc recalls Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Recalled February 19, 2020 · FDA recall Z-1122-2020 · Flowonix Medical
Hazard
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. · FDA Class II
Units
6670 (US)
Sold at
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
Description
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.
Product
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Manufacturer(s)
Flowonix Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →