Flowonix Medical Inc
Mansfield, MA
This page shows every FDA and USDA recall linked to Flowonix Medical Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
12
Total Recalls
2019
First Recall
2021
Most Recent
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following:
Prometra Progr...
May 26, 2021
· Device
Terminated
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 0081033...
Feb 10, 2020
· Device
Open, Classified
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 0081033...
Feb 10, 2020
· Device
Open, Classified
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Feb 10, 2020
· Device
Open, Classified
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 008...
Feb 10, 2020
· Device
Open, Classified
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 0081...
Feb 10, 2020
· Device
Open, Classified
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Feb 10, 2020
· Device
Open, Classified
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Mar 21, 2019
· Device
Terminated
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and P...
Mar 21, 2019
· Device
Terminated
Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
Mar 21, 2019
· Device
Terminated
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II...
Mar 21, 2019
· Device
Terminated
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Mar 21, 2019
· Device
Terminated