medical Class II Updated 2020-02-19

Flowonix Medical Inc recalls Prometra II 40mL Pump. Catalog No. 16827 The device is an im

Recalled Product

Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10GC4A24X 10GC4A02X 10GC4A18X 10GC4A22X 10GC4A14X 4MA00044X 4MA00006X 10GC4A12X 10GC4A09X 10GC4A06X 10GC4A21X 4MA00008X 10GC4A01X 10GC4A20X 10GC4A11X 10GC4A16X 10GC4A17X 4MA00045X 4MA00055X 10GC4A08X 4MA00032X 4MA00031X 4MA00010X 4MA00042X
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