Drug recall
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra…
FDA recall event 88044 · Class II · Flowonix Medical Inc
Key facts
| Event ID | 88044 |
|---|---|
| Recall numbers | Z-1996-2021 |
| Recalling firm | Flowonix Medical Inc |
| Product type | Devices |
| Products | Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as… |
| Initiation date | May 26, 2021 |
| Report date | Jul 7, 2021 |
| Termination date | Feb 20, 2024 |
| City | Mansfield |
| State | MA |
| Country | United States |
| FEI number | 3010079947 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: