Device recall
Z-2740-2017: PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog…
FDA device recall · Class II · Flowonix Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2740-2017 |
|---|---|
| Recall event | 77442 |
| Product | 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 of the device plus the following Prometra II pump labeling is also being revised: Intrathecal… |
| Product code | LKK |
| Recalling firm | Flowonix Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2018 |
| PMA numbers | P080012 |
| FEI number | 3006803715 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database