The Recall Desk

FDA (Devices) recall action 73744

B Braun Medical Inc recalled 6 products on 2016-05-11

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2016-05-11
Critical
1
Units
1,033

Why these products were recalled

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • SevereFDA (Devices)··2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

    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 ce
    Category
    Distribution
    31 states
  • CriticalFDA (Devices)··2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A 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 c
    Category
    Distribution
    31 states
  • HighFDA (Devices)··2016-05-11

    B Braun Dialog+ Hemodialysis Machines Recalled for Potential Sensor Leakage

    B Braun Medical Inc. is recalling 40 Dialog+ Hemodialysis machines due to a potential leakage issue with conductivity sensors.

    Product
    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 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,
    Category
    Distribution
    31 states
  • HighFDA (Devices)··2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 90 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 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
    Category
    Distribution
    31 states
  • HighFDA (Devices)··2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage

    B Braun Medical Inc is recalling 318 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    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 hosp
    Category
    Distribution
    31 states
  • SevereFDA (Devices)··2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 147 Dialog+ Hemodialysis Conductivity Sensors due to potential leakage. The sensors are used in dialysis machines for kidney failure patients.

    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 cen
    Category
    Distribution
    31 states