The Recall Desk
HighFDA (Devices)·Z-1534-2016·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for leakage, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

B Braun Medical Inc is recalling 90 units of Dialog+ Hemodialysis machines (Product Code 710200U, Serial Numbers 202136 through 203837). The recall is being conducted because the conductivity sensors on these machines have the potential to leak.

The affected machines are used to implement and monitor hemodialysis treatments for patients with acute or chronic kidney failure. These devices are utilized in hospital, health center, and outpatient dialysis center settings when prescribed by a physician.

The recalled 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 contact B Braun Medical Inc for instructions on how to address the potential leakage issue.

The recalled product

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
Hazard
Affected units
90

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 (2)

  • Product Code 710200 USerial Number Range
  • 202136-203837

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 →