Recall Z-1531-2016— B Braun Medical Inc

Name: FDA recall Z-1531-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-01

Class I · Terminated

Class I FDA medical device recall by B Braun Medical Inc, initiated 2016-04-01, terminated 2017-07-11. It names 2 FDA 510(k) clearances: K083460, K963440. 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..

Recalling firm: B Braun Medical Inc
Classification: Class I
Status: Terminated
Initiated: 2016-04-01
Terminated: 2017-07-11
Firm location: Bethlehem, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K083460 — DIALOG WITH ADIMEA OPTIONB. Braun Avitum AG·cleared 2010-02-18
K963440 — DIALOG DIALYSIS MACHINEB. Braun Medical AG·cleared 1998-06-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Data sourced from openFDA. This site is unofficial and independent of the FDA.