Drug recall
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number…
FDA recall event 77442 · Class II · Flowonix Medical, Inc.
Key facts
| Event ID | 77442 |
|---|---|
| Recall numbers | Z-2740-2017 |
| Recalling firm | Flowonix Medical, Inc. |
| Product type | Devices |
| Products | PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an… |
| Initiation date | May 22, 2017 |
| Report date | Jul 26, 2017 |
| Termination date | Jun 28, 2018 |
| City | Mount Olive |
| State | NJ |
| Country | United States |
| FEI number | 3006803715 |
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: