Device recall
Z-2129-2019: Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product…
FDA device recall · Class II · Burlington Medical, LLC
Key facts
| Recall number (Z-number) | Z-2129-2019 |
|---|---|
| Recall event | 83144 |
| Product | Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user. |
| Product code | EAJ |
| Recalling firm | Burlington Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2023 |
| FEI number | 1000120804 |
At a glance
- None Linked 510(k)s
- 10–99 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