Flowonix Medical Inc
Complete recall history across all FDA and CPSC categories — 12 total recalls
Flowonix Medical Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (12)
FDA medical device enforcement actions by Flowonix Medical Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| May 26, 2021 | Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used wi... | Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued du... | Class II |
| Dec 24, 2019 | Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusio... | A pump alarm function anomaly in the pump firmware code may result in the pum... | Class II |
| Dec 24, 2019 | Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an impla... | A pump alarm function anomaly in the pump firmware code may result in the pum... | Class II |
| Dec 24, 2019 | Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantab... | A pump alarm function anomaly in the pump firmware code may result in the pum... | Class II |
| Dec 24, 2019 | US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implan... | A pump alarm function anomaly in the pump firmware code may result in the pum... | Class II |
| Dec 24, 2019 | Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantab... | A pump alarm function anomaly in the pump firmware code may result in the pum... | Class II |
| Dec 24, 2019 | Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusio... | A pump alarm function anomaly in the pump firmware code may result in the pum... | Class II |
| Mar 21, 2019 | Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal in... | The pump shuts down unexpectedly if Error 115, an alarm associated with a wat... | Class II |
| Mar 21, 2019 | Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion. | The pump shuts down unexpectedly if Error 115, an alarm associated with a wat... | Class II |
| Mar 21, 2019 | Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, u... | The pump shuts down unexpectedly if Error 115, an alarm associated with a wat... | Class II |
| Mar 21, 2019 | Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No... | The pump shuts down unexpectedly if Error 115, an alarm associated with a wat... | Class II |
| Mar 21, 2019 | Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion. | The pump shuts down unexpectedly if Error 115, an alarm associated with a wat... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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