Device recall
Z-1125-2020: Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an…
FDA device recall · Class II · Flowonix Medical Inc
Key facts
| Recall number (Z-number) | Z-1125-2020 |
|---|---|
| Recall event | 84653 |
| Product | Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific) |
| Product code | LKK |
| Recalling firm | Flowonix Medical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P080012 |
| FEI number | 3010079947 |
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