FDA-Device2020-02-19Class II
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Flowonix Medical Inc
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.
Sold states
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
Affected count
6670 (US)
Manufactured in
120 Forbes Blvd Ste 170, Mansfield, MA, United States
Products
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1122-2020Don't want to check this manually?
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