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.
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 40 units of Dialog+ Hemodialysis machines (Product Code 710200K, Serial Numbers 202169 through 203249). The recall is due to a potential leakage of conductivity sensors in the devices.
These machines are used to implement and monitor hemodialysis treatments for patients with acute or chronic kidney failure. The affected units were distributed nationwide to facilities in 30 states, Puerto Rico, and the U.S. Virgin Islands.
The source text does not specify specific instructions for consumers or healthcare providers regarding the recall.
The recalled product
- 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…
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Hemodialysis
- Hazard
- Affected units
- 40
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 (3)
- Product Code 710200K
- Serial Number Range
- 202169 - 203249
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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