FDA Device recall Z-1531-2016
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementi…
- 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 A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementi… 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-1531-2016 |
| 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 A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 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 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014. |
|---|
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-1531-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.