The Recall Desk
SevereFDA (Devices)·Z-1536-2016·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences.

Plain-English summary

B Braun Medical Inc is recalling 147 units of the Dialog+ Hemodialysis Conductivity Sensor (Item 3456103A). The recall is due to a potential leakage issue with the sensors. These sensors are components of the Dialog+ Hemodialysis machines, which are used to implement and monitor hemodialysis treatments for patients with acute or chronic kidney failure in hospital, health center, and outpatient dialysis center settings.

The affected units were distributed nationwide to facilities in North Dakota, Ohio, California, Virginia, Florida, Louisiana, South Carolina, Illinois, Utah, Arizona, Kentucky, Iowa, Wisconsin, Oklahoma, Tennessee, South Dakota, Alabama, New Jersey, Texas, New Mexico, New York, Kansas, Washington, Missouri, Colorado, Pennsylvania, Connecticut, Delaware, Georgia, Maryland, Puerto Rico, and St. Thomas USVI.

Healthcare facilities should stop using the affected conductivity sensors and contact B Braun Medical Inc for further instructions. Patients using these machines should consult their healthcare providers regarding the recall.

The recalled product

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
Hazard
Affected units
147

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Item # 3456103A

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 6 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →