The Recall Desk
HighFDA (Devices)·Z-1532-2016·Announced 2016-05-11

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.

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 medical device used for life-sustaining treatment (hemodialysis) with a potential mechanical defect (leakage). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it does not meet the criteria for Severe (4) such as FDA Class II with hospitalization reports or structural vehicle defects.

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 hospital,
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

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 · leakage

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