Agency classClass IOur severity:Severe FDA (Devices)·Z-1533-2016·Announced 2016-05-11

B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage

B Braun Medical Inc is recalling 318 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 318 units of the Dialog+ Hemodialysis machine (Product Code 710200S, Serial Numbers 200805 through 204001). The recall is due to a potential leakage of the 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 31 states, Puerto Rico, and the U.S. Virgin Islands.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product: Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 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 — Dialysis Equipment
Hazard: sensor-leakage
Affected units: 318

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 710200S Serial Number Range
200805-204001

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 →

Same manufacturer · B Braun Medical Inc

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