The Recall Desk
HighFDA (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.

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 high-risk medical device (hemodialysis) with a defect that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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 hosp
Manufacturer
B Braun Medical Inc
Category
Medical Device — Dialysis Equipment
Hazard
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 →

Related recalls

Same manufacturer · B Braun Medical Inc

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Same hazard · sensor leakage

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