Device recall
Z-1409-2020: Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1409-2020 |
|---|---|
| Recall event | 84339 |
| Product | Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L |
| Product code | KDI |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| 510(k) numbers | K130039 |
| FEI number | 1417572 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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