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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential leakage of conductivity sensors of the Dialog Dialysis machines."
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…
- Manufacturer
- B Braun Medical Inc
- 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
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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