Device recall
Z-1996-2021: Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with…
FDA device recall · Class II · Flowonix Medical Inc
Key facts
| Recall number (Z-number) | Z-1996-2021 |
|---|---|
| Recall event | 88044 |
| Product | 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 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228… |
| Product code | LKK |
| Recalling firm | Flowonix Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 20, 2024 |
| 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