FDA Device recall Z-1533-2016
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used…
- FDA Device
- Class I
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class I recall of Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used… by B Braun Medical, citing potential leakage of conductivity sensors of the Dialog Dialysis machines.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1533-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-04-01 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 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 prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Reason
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Identifiers
| code_info | Product Code 710200S Serial Number Range; 200805-204001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2016%22
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