Device recall
Z-2193-2020: Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-2193-2020 |
|---|---|
| Recall event | 85514 |
| Product | Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. |
| Product code | FJK |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2023 |
| 510(k) numbers | K070414, K100364 |
| FEI number | 1417572 |
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