Device recall
Z-2697-2014: UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm)…
FDA device recall · Class II · Argon Medical Devices, Inc
Key facts
| Recall number (Z-number) | Z-2697-2014 |
|---|---|
| Recall event | 68521 |
| Product | UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. |
| Product code | MSD |
| Recalling firm | Argon Medical Devices, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2015 |
| 510(k) numbers | K023847, K102043 |
| FEI number | 1625425 |
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