Device recall
Z-0199-2022: The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a…
FDA device recall · Class II · Bayer Medical Care, Inc.
Key facts
| Recall number (Z-number) | Z-0199-2022 |
|---|---|
| Recall event | 88807 |
| Product | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system. |
| Product code | DXT |
| Recalling firm | Bayer Medical Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2023 |
| 510(k) numbers | K132928 |
| FEI number | 2520313 |
At a glance
- 1–9 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