Device recall
Z-0030-2020: L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-0030-2020 |
|---|---|
| Recall event | 83191 |
| Product | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2020 |
| 510(k) numbers | K102936 |
| 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