Agency classClass IOur severity:Severe FDA (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.

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 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…
Manufacturer: B Braun Medical Inc
Category: Medical Device — Hemodialysis Equipment
Hazard: sensor-leakage
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 →

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Same hazard · sensor leakage