Device recall
Z-1536-2016: Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The…
FDA device recall · Class I · B Braun Medical Inc
Key facts
| Recall number (Z-number) | Z-1536-2016 |
|---|---|
| Recall event | 73744 |
| Product | Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when… |
| Product code | KDI |
| Recalling firm | B Braun Medical Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 11, 2017 |
| 510(k) numbers | K083460, K963440 |
| FEI number | 2521402 |
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