The Recall Desk
SevereFDA (Devices)·Z-1531-2016·Announced 2016-05-11

B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class I recall, which per the rubric mandates a minimum severity score of 4 (Severe).

Plain-English summary

B Braun Medical Inc is recalling 370 units of Dialog+ Hemodialysis machines (Product Code 710200L, Serial Numbers 200318 through 203922). These machines are used to implement and monitor hemodialysis treatments for patients with acute or chronic kidney failure in hospital, health center, and outpatient dialysis center settings.

The recall was initiated due to a potential leakage of conductivity sensors in the affected devices. The units were distributed between August 5, 2013, and July 7, 2014, to facilities in 31 states, Puerto Rico, and St. Thomas, USVI.

Healthcare facilities should stop using the affected units and contact B Braun Medical Inc for further instructions. Patients should consult their healthcare providers regarding the recall and any necessary changes to their dialysis treatment plans.

The recalled product

Product
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 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, health ce
Manufacturer
B Braun Medical Inc
Category
Medical Device — Hemodialysis Equipment
Hazard
Affected units
370

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 710200L
  • Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.

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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