Device recall
Z-1983-2020: BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max…
FDA device recall · Class II · Access Scientific LLC
Key facts
| Recall number (Z-number) | Z-1983-2020 |
|---|---|
| Recall event | 85586 |
| Product | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a… |
| Product code | FMF |
| Recalling firm | Access Scientific LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| FEI number | 3009549229 |
At a glance
- None Linked 510(k)s
- 10–99 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