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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls are classified as Critical (Score 5) regardless of other factors.
Plain-English summary
B Braun Medical Inc is recalling 68 units of the Dialog+ Hemodialysis Conductivity Sensor (Item # 3456102A). The recall is being conducted because of a potential leakage issue with the sensors. These sensors are components used in Dialog+ Hemodialysis machines, which are prescribed for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure.
The affected sensors 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. The devices are used in hospital, health center, and outpatient dialysis center settings.
This is an FDA Class I recall. Healthcare facilities and consumers should stop using the affected conductivity sensors immediately and contact B Braun Medical Inc for instructions on replacement or return.
The recalled product
- 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…
- Manufacturer
- B Braun Medical Inc
- Hazard
- Affected units
- 68
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 # 3456102A
Distribution
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.
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