Device recall
Z-0605-03: Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter…
FDA device recall · Class III · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0605-03 |
|---|---|
| Recall event | 25079 |
| Product | Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to… |
| Product code | KDI |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 19, 2003 |
| 510(k) numbers | K961700 |
| FEI number | 1416980 |
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