Device recall
Z-2550-2020: POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell…
FDA device recall · Class III · Access Scientific LLC
Key facts
| Recall number (Z-number) | Z-2550-2020 |
|---|---|
| Recall event | 85808 |
| Product | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular… |
| Product code | OWL |
| Recalling firm | Access Scientific LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 30, 2024 |
| FEI number | 3009549229 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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